Zantac / Ranitidine Litigation Common Misconceptions By John Ray

The topic below will be discussed in depth in the Mass Tort Nexus (MTN) Whiteboard Wednesday (January 20, 2021), if you have not registered for the session, you can do so here: https://www.masstortnexus.com/Whiteboard

Common Misconception: Sales of prescription versions of Zantac/Ranitidine were insignificant after the OTC versions were approved.

Fact: Sales of prescription versions of Zantac/Ranitidine remained strong even after the OTC versions were approved. Between 18 million and 20 million prescriptions were written for Zantac/Ranitidine, each year, over the last decade. Zantac/Ranitidine made the list of “Top 50 Most Prescribed Drugs” every single year over the last decade.

Why is this important?

  1. There will be a potentially far greater number of potential Zantac/Ranitidine “prescription use” plaintiffs.
  2. Due to the significant number of arguably counterfeit Zantac/Ranitidine finished drugs, placed into the stream of commerce by “repacking entities,” combined with the fact that the FDA has discovered these products and deactivated the NDC codes for many of these products, it is highly unlikely that your firm has a complete list of Zantac/Ranitidine NDC codes.

Why does this matter?

1. When the FDA deactivates an NDC code, it is removed from the public database of active NDC codes. MTN has uncovered and compiled these deactivated NDC codes.
2. Firms accepting Zantac/Ranitidine clients may believe they have a full list of all Zantac/Ranitidine NDC codes; however, it is improbable that any firm is working from a complete list of codes (it took MTN over 9 months to locate all Zantac/Ranitidine NDC codes, including those that have been deactivated by the FDA, or removed from the public view for other reasons).

Why is having a complete list of NDC codes critical?

  1. Your firm has a prospective client that claims to have taken prescription Zantac/Ranitidine, you sign the client and order their pharmacy records.
  2. Your record review department or company reviews the pharmacy and/or insurance records, looking for Zantac/Ranitidine NDC codes; the proof that your client did, in fact, consume a prescription Zantac/Ranitidine product.
  3. If you are not working from a complete list of Zantac/Ranitidine NDC codes (which is likely), then your record review may conclude that your client who claims to have taken prescription Zantac/Ranitidine, did not, because the NDC code for the product they consumed is not on the “incomplete” list of NDC codes in your possession.

Additionally, once you have access to a comprehensive list of NDC codes, you are likely to discover that many of your clients consumed one of the repackaged (arguably counterfeit) versions of prescription Zantac/Ranitidine.

In addition to the reasons previously stated, identifying all of your clients who took repackaged (arguably counterfeit) versions of Zantac/Ranitidine, is also crucial for the following reasons:

  1. Overcoming PLIVA v Mensing (in addition to the other facts that make Mensing inapt).
  2. A majority of the repacking entities are located in California, were the JCCP has already established an MDL-like consolidation for these cases.
  3. Given the ever-growing appearance, that the Zantac/Ranitidine MDL has landed in the hands of a defense-friendly Judge, the ability to establish jurisdiction and file cases in various State Court Consolidation, is now of paramount importance.

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THE ZANTAC DEFENDANTS ARE DETERMINED TO THROW OUT YOUR CASES!

HOW TO PREVENT DISMISSAL OF YOUR GENERIC ZANTAC CASES

OUR WHITEBOARD WEDNESDAY ON DECEMBER 16TH IS AN ABSOLUTE MUST FOR YOUR ZANTAC CASES.

Are you aware that the DEFENDANTS will be actively attempting to have your Plaintiff’s cases thrown out by claiming that they have stopped marketing that particular Zantac/Ranitidine product based on their “end marketing” dates. YOU WILL UNDERSTAND HOW TO COUNTER THIS TACTIC AND SAVE YOUR CASES after participating in Whiteboard Wednesday on 12/16 (2PM-4PM EST).

Mass Tort Nexus has unraveled and uncovered a far-reaching CONSPIRACY (and identified the major conspirators) that produced, packaged, distributed and sold approximately 1,000 various Ranitidine products by employing a scheme involving obtaining multiple National Drug Code’s (NDC), for finished products with branding and labeling that was never approved by the FDA and for that matter, could not be approved by the FDA. Per (21 CFR §207.37 (a)(2), Assignment of an NDC number does not in any way denote FDA approval of the product. Any representation that “creates an impression of official approval because of possession of an NDC number is misleading and constitutes misbranding.

IT’S A BOMBSHELL!

In a nutshell, a single Ranitidine drug maker would obtain FDA approval for the generic (ANDA) that included labeling for a single finished product, (in various sizes/counts) for sale to a retail class of consumers. That drug maker would then fill and ship large containers (drums of up to 60,000 pills) to a repackaging company. The repackaging company would repackage at a smaller scale with retail store branding and labeling. This “repackaging” was never approved by the FDA. These are counterfeit finished drugs. Under NO circumstances is a repackaged product to end up on a retail shelf as an OTC drug in any store…it is illegal.

The creation of counterfeit finished drug products as described above, is a Federal crime. In violation of 21 U.S. Code § 331 (k), § 331 (a) and § 331 (b) and is punishable under of 21 U.S. Code § 333 by up to 10 years in prison and a $10,000.00 fine for each individual unit of product entered into the stream of commerce.

ONCE YOU UNDERSTAND THE LAWS/REGULATIONS SURROUNDING THIS, YOU WILL BE ARMED TO IDENTIFY A COUNTERFEIT RANITIDINE PRODUCT IN VIOLATION OF 21 U.S. Code § 331. THRU REVIEW OF THE SPL (STRUCTED PRODUCT LABELING) INFORMATION AND OTHER EVIDENCE IN OUR POSESSION. WITH THIS INFORMATION AND EVIDENCE IN HAND, YOU WILL BE ABLE TO DISCREDIT ANY AVERMENTS OF THESE DEFENDANTS CLAIMING THAT THEY HAD CEASED MARKETING A GIVEN PRODUCT AT THE TIME YOUR CLIENT CLAIMS TO HAVE PURCHASED THAT PRODUCT.

To provide clarity on WHAT THE DEFENDANTS ARE HIDING, you will receive John Ray’s White Paper prior to 12/16 for your review AND all of this ground-breaking information will be discussed in further detail on the Zantac/Ranitidine Whiteboard Wednesday (2PM-4PM EST).

REGISTER NOW-WE ARE APPROACHING CAPACITY.

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HOW TO PREVENT DISMISSAL OF YOUR GENERIC ZANTAC CASES

OUR WHITEBOARD WEDNESDAY ON DECEMBER 16TH IS CRUCIAL TO YOUR ZANTAC MDL CASES.

To date, there are more than 50,000 cases filed into the Zantac/Ranitidine MDL.

Are you aware that the DEFENDANTS will be actively attempting to have your Plaintiff’s cases thrown out by claiming that they have stopped marketing that particular Ranitidine product based on their “end marketing” dates. YOU WILL UNDERSTAND HOW TO COUNTER THIS TACTIC AND SAVE YOUR CASES after participating in Whiteboard Wednesday.

MTN has unraveled a far-reaching conspiracy (and identified the major conspirators) that produced, packaged, distributed and sold approximately 1,000 various Ranitidine products by employing a scheme involving obtaining multiple National Drug Code’s, for finished products with branding and labeling that was never approved by the FDA and for that matter, could not be approved by the FDA.

Although the appearance of an NDC code on a finished drug product might lead a consumer to believe that product, as labeled, was approved by the FDA, nothing could be further from the truth.

Assignment of an NDC number does not in any way denote FDA approval of the product. Any representation that creates an impression of official approval because of possession of an NDC number is misleading and constitutes misbranding. (21 CFR §207.37 (a)(2))

This is how the scheme worked: A single drug maker would obtain ANDA approval, including the labeling for a single finished product, in various sizes or counts appropriate for sale to a retail class of consumers. That ANDA holder would then fill large containers, up to drums of 60,000 pills, which would be shipped to a repacking company. The repacking company would remove the pills from the bulk containers and fill containers with retail store branding and labeling not approved by the FDA.

The narrow allowance for repackaging approved drug products is limited to the ANDA or NDA holder allows repacking entity to produce containers in counts or sizes not produced by the application holder, for sale to hospitals and other institutions. The only change permitted to the FDA approved labeling for the specific product is the addition of the repacking entities name and address, under the manufacturers name and address on the FDA approved labeling. Under no circumstance should a repackaged product end up on a retail shelf, behind the drug counter or as an OTC drug in the retail section of any store.

The creation of counterfeit finished drug products as described above, is a Federal crime in violation of 21 U.S. Code § 331 (k), § 331 (a) and § 331 (b) and is punishable under of 21 U.S. Code § 333 by up to 10 years in prison and a $10,000.00 fine for each individual unit of product entered into the stream of commerce.

MTN has reviewed, documented, and collected the NIH and FDA database information as well as other evidence of the roles the various conspirators played in the scheme. IT’S A BOMBSHELL!

ONCE YOU UNDERSTAND THE LAWS/REGULATIONS SURROUNDING THIS, YOU WILL BE ARMED TO IDENTIFY A COUNTERFEIT RANITIDINE PRODUCT IN VIOLATION OF 21 U.S. Code § 331. THRU REVIEW OF THE SPL (STRUCTED PRODUCT LABELING) INFORMATION AND OTHER EVIDENCE IN OUR POSESSION. WITH THIS INFORMATION AND EVIDENCE IN HAND, YOU WILL BE ABLE TO DISCREDIT ANY AVERMENTS OF THESE DEFENDANTS CLAIMING THAT THEY HAD CEASED MARKETING A GIVEN PRODUCT AT THE TIME YOUR CLIENT CLAIMS TO HAVE PURCHASED THAT PRODUCT.

THE DEFENDANTS THAT PARTICIPATED IN THE SCHEME COMPLETELY IGNORED THE REQUIREMENTS OF THE DRUG SUPPLY CHAIN SECURITY ACT (DSCSA). ANY CLAIM OR AVERMENT MADE BY THESE DEFENDANTS THAT CONTRADICTS A PLAINTIFFS CLAIM REGARDING WHEN THEY PURCHASED A GIVEN PRODUCT, CAN BE REFUTED WITH OFFICAL RECORDS AND OTHER EVIDENCE IN OUR POSESSION. ADDITIONALLY, THE VERACITY OF ANY AVERMENT MADE BY THESE DEFENDANTS CAN BE CHALLANGED.

To provide clarity on WHAT THE DEFENDANTS ARE HIDING, you will receive John Ray’s White Paper prior to 12/16 for your review AND all of this ground breaking information will all be discussed in further detail on the Zantac/Ranitidine Whiteboard Wednesday.

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WHAT THE ZANTAC GENERIC DEFENDANTS ARE HIDING

MASS TORT NEXUS IS ABOUT TO DROP A BOMBSHELL

After nine months and thousands of hours of research, MTN has finally unraveled the conspiracy (and identified most, if not all, of the conspirators) that led to the entry into interstate commerce of approximately 1000 counterfeit Ranitidine products, a crime, in violation of 21 U.S. Code § 331 (k).

MTN has reviewed all of the various NIH and FDA databases necessary to identify all Ranitidine NDC codes deactivated under Code I (this will all be explained).

What is the difference between the Recall of a Drug Product and an NDC Deactivation under Code I?

A recall of an approved drug product generally occurs when something new is discovered relevant to the risks associated with the approved product. A recall does not indicate that the product was unlawfully marketed in the first instance.

Conversely, the deactivation of an NDC code, for any reason other than Code “E” (expired), is prima facia evidence that the particular drug package or finished drug product was, at all times in commerce, in violation of one or more regulations that carry the force of law (civil) as well as other violations that can be subject to criminal prosecution. If you understand the laws and regulations, which you will after attending the Whiteboard Wednesday series on December 16th, you will be able to identify a counterfeit drug product as well as a product entered into the stream of commerce in violation of 21 U.S. Code § 331 (k), simply by reviewing the SPL dataset for that product, even if you are currently unfamiliar with the term “SPL date set”.

FYI: MTN has already identified all Ranitidine products entered into the stream of commerce in violation of 21 U.S. Code § 331 (k); however, we would like to teach you how to identify these violative products as the Zantac/Ranitidine litigation is not the only current litigation where these matters are relevant.

We did not end our review with the products the FDA has discovered and taken action via NDC code deactivation, we reviewed every label for every Ranitidine NDC code, ever marketed in the United States (including those in various NIH and FDA archives), in order to identify all products involved in what we now simply refer to as “the scheme”.

To the best of our knowledge, there have been no prior mass product liability litigations in which the FDA has deactivated a plurality of the products (by NDC code) long prior to the onset of the product liability litigation.

Among the benefits attendees will gain include:

  1. The ability to counter any Defendant that avers that they had stopped marketing a product before a given date, when a Plaintiff claims to have consumed that product. The “end marketing” date for any given drug product is part of an official record, for which the drug maker is responsible to maintain and update, the accuracy thereof being subject to oath under the penalty of perjury. The Defendant’s averments as to any alleged “end marketing date” are irrelevant, the official record governs. Defendants will be forced to pick their perjury: Did they perjure themselves in an official Federal Record, or are they now perjuring themselves before the MDL court?
  2. The ability to add allegations and claims to your complaints that are likely to make certain Defendants more amenable to settlement, sooner rather than later. Ranbaxy had to shell out approximately $525 billion in 2013, after the DOJ charged the drug maker with violations of 21 U.S. Code § 331 (k) (among other things). The breadth and scope of the 331 (k) charges brought against Ranbaxy pale in comparison to what MTN has discovered occurred among a large group of the Zantac generic conspirators. We have the proof!

This series of Whiteboard Wednesdays will only be open to MTN members or individual attorneys sponsored and vouched for by MTN members.

If you are not an MTN member, contact annemarie@masstortnexus.com or call 954-530-9892 to discover how to become a member of the largest network of mass tort attorneys in the country.

Upon completion of your Registration for Whiteboard Wednesday, you will receive a copy of our white paper that should be read prior to attending the first in this series of “Zantac Whiteboard Wednesdays”. We need to hit the ground running, and it is likely that you will need to act on behalf of your Zantac generic clients sooner rather than later, based on the knowledge and evidence provided.

Register now for the first in the series of Zantac Whiteboard Wednesdays, held on Wednesday, December 16th. The presentation runs from 2:00pm EST – 4:00pm EST with Q&A to follow.

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FDA REQUEST RECALL OF ALL ZANTAC/ RANTIDINE PRODUCTS. IS THIS THE TIP OF A MUCH LARGER ICEBERG? By JOHN RAY

On 04/01/2020, the FDA requested that all makers of all ranitidine drugs (Zantac and generics) remove their products from the market. The reasoning citied by the FDA “The FDA has determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures may result in consumer exposure to unacceptable levels of this impurity”. See entire press release at this link.

The reason the FDA has requested that all ranitidine (Zantac et.al) products be removed from the market go far beyond the reasons currently stated in the FDA press release.

PRIMARY TOPICS COVERED IN THIS ARTICLE

  1. The FDA may (and arguably should) demand the recall of all ‘histamine H2-receptor antagonists’ (227 approved products in total) as the “contamination issue” is not the primary defect or danger presented by these drugs. In more simple terms, these drugs most likely cause the production of high levels of N-Nitroso compounds when introduced in the human body, especially in individuals with higher than normal levels of acid in their stomach or GI tract. Why? ‘Histamine H2-receptor antagonists are nitrosatable.Nitrosatable: Capable of being converted into nitroso compounds also referred to as n-nitroso compounds. (See list of n-nitroso compounds in appendix A below)Nitrosatable Drug: Drugs Capable of being converted into nitroso compound also referred to as n- nitroso compounds.) Generally, the conversion to or production of the n- nitroso compound occurs when the drug interacts with the acidic compounds found in the stomach and gastrointestinal tract.
  2. The litigation resulting from the current ranitidine requested recall may dramatically increase in scope over the next year, to include all ‘histamine H2-receptor antagonists without regard to whether an individual consumed a product known to have been contaminated.
  3. The litigation will be complex as under certain scenarios cases involved ANDA approved products (generics) may be foreclosed on by Pliva v. Mensing, while under other circumstances Pliva v. Mensing may not foreclose on claims involving generics (this subject will be more thoroughly covered in future articles).
  4. The injuries or adverse events caused by the n-nitroso compounds, whether through contamination in the production process, aggravated by heat or due to the inherent nitrosatable properties of Histamine H2-receptor antagonists are not limited to cancer, the n-nitroso compounds produced by consumption of these drugs (without regard to contamination, not only are believed to cause cancer. The n-nitroso compounds in question are also known to cause major organ failure, still births and birth defects. The fact that pregnant women often have issues with stomach acidity and consume ‘histamine H2-receptor antagonists” to mitigate the pain associated with this ailment, is of significant concern to this researcher. (this subject will be more thoroughly covered in future articles)

THE ELEPHANT IN THE ROOM

The FDAs reasoning behind the requested recall of all ranitidine products being that the level or amount of the N-Nitroso impurity (contamination) increases when exposed to heat higher than room temperatures begs the following question:

Why is the FDA only requesting the removal of ranitidine products and not other products such as the various blood pressure medications (ie. Valsartan) that have also been found to be contaminated with N-Nitroso compounds?

There may be a simple answer to the question posed. Ranitidine like all other ‘histamine H2-receptor antagonists’ are nitrosatable while Valsartan et.al. drugs are not nitrosatable.

Histamine H2-Receptor Antagonists
Histamine H2-Receptor Antagonists also known as H2 blockers are a group of medicines that reduce the amount of acid produced by the cells in the lining of the stomach. They include cimetidine, famotidine, nizatidine and ranitidine, and have various brand names, including Zantac. (See Appendix B1, a list of all FDA approved ranitidine and Appendix B2 for a list of all other FDA approved ‘histamine H2-receptor antagonists’ (141 products)

Individuals take H2-receptor antagonists due to pain caused lower than normal PH Levels (more acidic) stomach and gastrointestinal “juices” than normal. The lining of the stomach and other structures in the gastrointestinal tract are not designed to resist degradation by acids with lower PH (more acidic) than the normal levels found in healthy individuals.

The scientific literature supports the conclusion that the introduction of a Nitrosatable Drug in a patient with lower than normal (more acidic) PH levels in their Stomach and GI tract, produces higher levels of as n-nitroso compounds than are produced with that same drug is introduced into the body of an individual with normal PH levels (normal acid levels) in their Stomach and GI tract see:

See: N-Nitrosamines in gastric juice of patients with gastric ulcer before and during treatment with histamine H2-receptor antagonists: https://link.springer.com/article/10.1007/BF02776810

REASONABLE CONCLUSION

Reasonable Conclusion: A Nitrosatable Drug designed to treat individuals known to have lower than normal PH levels in their Stomach and GI tract, is defective in concept and design in that the drug will arguably create higher levels of n- nitroso compounds in the group of individuals that the drug is intended to treat, versus a nitrosatable Drug designed to treat individuals not known to have lower than normal PH levels in their Stomach and GI tract (such as Valsartan). More simply stated, the drugs are intended to treat individuals with pre-existing conditions that make these individuals more susceptible to the significant adverse events that can result from consumption of the drug.

THE TIP OF A VERY LARGE ICEBERG

The issue arising from contamination certain lots of Valsartan and certain Ranitidine products was first brought to the attention of the FDA by a small company relatively young company Valisure, LLC (founded in 2015) operating out of New Haven Connecticut. See the record of communications between Valisure, LLC and the FDA at this link.

Valisure’s Harvard- and Yale-trained scientists have developed laser-based technology to analyze the chemical properties and ingredients of pharmaceutical products. The novel technology employs laser-induced, quantum shift emissions to address the variability and quality problems that pervade many pharmaceutical products throughout the US.

On an unrelated note that might be of interest to investors, Valisure, currently a privately held company, filed the required documents to make a public stock offering in 2019 see documents at this link.

Shortly after Valisure filed its first petition related to its findings of NDMA and other n-nitroso compounds found in certain lots of blood pressure drugs (Valsartan et.al.) and antacid drugs (Zantac et.al) the FDA began a rapid-fire succession of actions designed to remove certain lots of these products from the market. See the relevant FDA actions at this link.

The fact that the FDA has now requested the removal of all ranitidine drugs from the market, (without regard to specific lot contamination) while not requesting the same of those non-nitrosatable drugs (Valsartan) for which contaminated lots have been discovered, lead this researcher to the conclusion that the issue with the ranitidine and other H2 blockers, goes far beyond the fact that a limited number of lots were found to be contaminated with the same harmful compounds the drug produces when introduced into the human body, without regard to additional contamination during the manufacturing process.

APENDIX A
LIST OF N-NITOROS COMPOUNDS

NAA N-nitrosoamino acids
NDBA N-nitrosodibutylamine
NDBZA N-nitrosodibenzylamine
NDEA N-Nitrosodiethylamine
NDMA N-Nitrosodimethylamine
NDPA N-Nitrosodipropylamine
NHMT N-nitroso-2-(hydroxymethyl)thiazolidine
NHMTCA N-nitroso-2-hydroxymethylthiazolidine-4-carboxylic acid
NHPRO N-nitroso-4-hydroxyproline
NMAMBA N-nitroso-N-(1-methylacetonyl)-3-methylbutylamine
NMEA N-Methyl-N-ethylnitrosamine
NMOCA N-nitroso-5-methyloxazolidine-4-carboxylic acid
NMOR N-nitrosomorpholine
NMTCA N-nitroso-2-methylthiazolidine-4-carboxylic acid
NPIP N-nitrosopiperidine
NPYR N-nitrosopyrrolidine
NPRO N-nitrosoproline
NSAR N-nitrososarcosine
NTCA N-nitrosothiazolidine-4-carboxylic acid
NTHZ N-nitrosothiazolidine
NTHZCA N-nitrosothiazolidine carboxylic acid and related homologues
N03 Nitrate
NO2 Nitrite

APPENDIX B1
LIST OF ALL FDA APPROVED H2 RECEPTOR ANTAGONIST CONTAINING RANITINIDINE or RANITINIDINE HYRDROCHLORIDE ( 86 Products)

ZANTAC 150 (RANITIDINE HYDROCHLORIDE) | NDA #018703 | TABLET;ORAL | GLAXO GRP LTD
ZANTAC 150 (RANITIDINE HYDROCHLORIDE) | NDA #020251 | TABLET, EFFERVESCENT;ORAL | GLAXO   GRP LTD
ZANTAC (RANITIDINE HYDROCHLORIDE) | NDA #019090 | INJECTABLE;INJECTION | TELIGENT
ZANTAC (RANITIDINE HYDROCHLORIDE) | NDA #019675 | SYRUP;ORAL | GLAXO GRP LTD
ZANTAC 25 (RANITIDINE HYDROCHLORIDE) | NDA #020251 | TABLET, EFFERVESCENT;ORAL | GLAXO GRP LTD
ZANTAC 300 (RANITIDINE HYDROCHLORIDE) | NDA #020095 | CAPSULE;ORAL | GLAXOSMITHKLINE
ZANTAC 300 (RANITIDINE HYDROCHLORIDE) | NDA #018703 | TABLET;ORAL | GLAXO GRP LTD
ZANTAC 75 (RANITIDINE HYDROCHLORIDE) | NDA #020520 | TABLET;ORAL | SANOFI US
ZANTAC 75 (RANITIDINE HYDROCHLORIDE) | NDA #020745 | TABLET, EFFERVESCENT;ORAL | SANOFI US
   ZANTAC IN PLASTIC CONTAINER (RANITIDINE HYDROCHLORIDE) | NDA #019593 | INJECTABLE;INJECTION | TELIGENT
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #074864 | TABLET;ORAL | WATSON LABS
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #075000 | TABLET;ORAL | RANBAXY
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #075094 | TABLET;ORAL | CONTRACT PHARMACAL
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #075132 | TABLET;ORAL | SUN PHARM INDS LTD
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #075165 | TABLET;ORAL | HERITAGE PHARMA
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #075167 | TABLET;ORAL | APOTEX INC
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #075180 | TABLET;ORAL | PAR PHARM
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #075208 | TABLET;ORAL | WOCKHARDT LTD
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #075212 | TABLET;ORAL | ANI PHARMS INC
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #075254 | TABLET;ORAL | RANBAXY
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #075294 | TABLET;ORAL | DR REDDYS LABS LTD
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #075296 | TABLET;ORAL | ANI PHARMS INC
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #075439 | TABLET;ORAL | SUN PHARM INDS LTD
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #075497 | TABLET;ORAL | MYLAN
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #075519 | TABLET;ORAL | SANDOZ
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #075557 | CAPSULE;ORAL | TEVA
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #075564 | CAPSULE;ORAL | MYLAN
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #075742 | CAPSULE;ORAL | DR REDDYS LABS LTD
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #074023 | TABLET;ORAL | MYLAN
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #074467 | TABLET;ORAL | SANDOZ
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #074488 | TABLET;ORAL | ANI PHARMS INC
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #074552 | TABLET;ORAL | MYLAN
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #074655 | CAPSULE;ORAL | SANDOZ
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #074662 | TABLET;ORAL | BOEHRINGER INGELHEIM
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #074680 | TABLET;ORAL | APOTEX
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #074764 | INJECTABLE;INJECTION | BEDFORD
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #074777 | INJECTABLE;INJECTION | WEST-WARD PHARMS INT
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #076705 | TABLET;ORAL | DR REDDYS LABS INC
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #076760 | TABLET;ORAL | WOCKHARDT
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #076195 | TABLET;ORAL | PERRIGO
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #076124 | SYRUP;ORAL | ACTAVIS MID ATLANTIC
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #077405 | SYRUP;ORAL | PHARM ASSOC
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #077458 | INJECTABLE;INJECTION | WEST-WARD PHARMS INT
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #077476 | SYRUP;ORAL | TARO
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #077426 | TABLET;ORAL | ANI PHARMS INC
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #078192 | TABLET;ORAL | DR REDDYS LABS LTD
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #077824 | TABLET;ORAL | AMNEAL PHARMS NY
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #078701 | TABLET;ORAL | WOCKHARDT
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #078684 | SYRUP;ORAL | BRECKENRIDGE
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #077602 | SYRUP;ORAL | APOTEX INC
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #078312 | SYRUP;ORAL | AMNEAL PHARMS
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #078448 | SYRUP;ORAL | RANBAXY
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #078542 | TABLET;ORAL | GLENMARK PHARMS INC
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #078653 | TABLET;ORAL | WOCKHARDT
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #078884 | TABLET;ORAL | WOCKHARDT
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #078890 | SYRUP;ORAL | LANNETT CO INC
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #090054 | SYRUP;ORAL | ANDA REPOSITORY
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #090102 | SYRUP;ORAL | TORRENT
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #079076 | INJECTABLE;INJECTION | MYLAN LABS LTD
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #079211 | SYRUP;ORAL | WOCKHARDT
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #079212 | SYRUP;ORAL | WOCKHARDT
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #200536 | TABLET;ORAL | STRIDES PHARMA
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #201745 | TABLET;ORAL | STRIDES PHARMA
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #091288 | SYRUP;ORAL | LANNETT CO INC
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #091534 | INJECTABLE;INJECTION | ZYDUS PHARMS USA INC
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #091078 | SYRUP;ORAL | HI TECH PHARMA
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #091091 | SYRUP;ORAL | NOSTRUM LABS INC
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #090623 | SYRUP;ORAL | AUROBINDO PHARMA LTD
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #091429 | TABLET;ORAL | PERRIGO R AND D
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #200172 | TABLET;ORAL | APOTEX INC
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #203694 | TABLET;ORAL | ACIC PHARMS
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #205512 | TABLET;ORAL | STRIDES PHARMA
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #211893 | CAPSULE;ORAL | APPCO
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #210228 | TABLET;ORAL | UNIQUE PHARM LABS
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #210243 | TABLET;ORAL | GRANULES INDIA LTD
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #210250 | TABLET;ORAL | UNIQUE PHARM LABS
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #209859 | CAPSULE;ORAL | AJANTA PHARMA LTD
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #210010 | TABLET;ORAL | STRIDES PHARMA
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #210681 | CAPSULE;ORAL | NOVITIUM PHARMA
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #211058 | CAPSULE;ORAL | AUROBINDO PHARMA LTD
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #211289 | TABLET;ORAL | VKT PHARMA PVT LTD
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #209160 | TABLET;ORAL | STRIDES PHARMA
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #209161 | TABLET;ORAL | STRIDES PHARMA
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #207578 | TABLET;ORAL | AUROBINDO PHARMA LTD
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #207579 | TABLET;ORAL | AUROBINDO PHARMA LTD
    RANITIDINE (RANITIDINE) | ANDA #074794 | SOLUTION; ORAL | ACTAVIS ELIZABETH

APPENDIX B2
LIST OF ALL FDA APPROVED H2 RECEPTOR ANTAGONIST (141 Products)

AXID (NIZATIDINE) | NDA #021494 | SOLUTION;ORAL | BRAINTREE
AXID (NIZATIDINE) | NDA #019508 | CAPSULE;ORAL | SMITHKLINE BEECHAM
AXID AR (NIZATIDINE) | NDA #020555 | TABLET;ORAL | GLAXOSMITHKLINE
NIZATIDINE (NIZATIDINE) | ANDA #075934 | CAPSULE;ORAL | MYLAN PHARMS INC
NIZATIDINE (NIZATIDINE) | ANDA #075616 | CAPSULE;ORAL | WATSON LABS
NIZATIDINE (NIZATIDINE) | ANDA #075668 | CAPSULE;ORAL | ANI PHARMS INC
NIZATIDINE (NIZATIDINE) | ANDA #075806 | CAPSULE;ORAL | MYLAN PHARMS INC
NIZATIDINE (NIZATIDINE) | ANDA #075461 | CAPSULE;ORAL | ANI PHARMS INC
NIZATIDINE (NIZATIDINE) | ANDA #076383 | CAPSULE;ORAL | APOTEX INC
NIZATIDINE (NIZATIDINE) | ANDA #076178 | CAPSULE;ORAL | SANDOZ
NIZATIDINE (NIZATIDINE) | ANDA #090576 | SOLUTION;ORAL | AMNEAL PHARMS
NIZATIDINE (NIZATIDINE) | ANDA #090618 | CAPSULE;ORAL | GLENMARK GENERICS
NIZATIDINE (NIZATIDINE) | ANDA #077314 | CAPSULE;ORAL | DR REDDYS LABS LTD
TAGAMET (CIMETIDINE) | NDA #017920 | TABLET;ORAL | GLAXOSMITHKLINE
TAGAMET (CIMETIDINE HYDROCHLORIDE) | NDA #017924 | SOLUTION;ORAL | GLAXOSMITHKLINE
TAGAMET (CIMETIDINE HYDROCHLORIDE) | NDA #017939 | INJECTABLE;INJECTION | GLAXOSMITHKLINE
TAGAMET HB (CIMETIDINE) | NDA #020238 | TABLET;ORAL | MEDTECH PRODUCTS
TAGAMET HB 200 (CIMETIDINE) | NDA #020951 | SUSPENSION;ORAL | GLAXOSMITHKLINE
TAGAMET HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (CIMETIDINE HYDROCHLORIDE) | NDA #019434 | INJECTABLE;INJECTION | GLAXOSMITHKLINE
CIMETIDINE (CIMETIDINE) | ANDA #074890 | TABLET;ORAL | HIKMA
CIMETIDINE (CIMETIDINE) | ANDA #074948 | TABLET;ORAL | APOTEX
CIMETIDINE (CIMETIDINE) | ANDA #074972 | TABLET;ORAL | PERRIGO
CIMETIDINE (CIMETIDINE) | ANDA #074961 | TABLET;ORAL | CONTRACT PHARMACAL
CIMETIDINE (CIMETIDINE) | ANDA #074963 | TABLET;ORAL | CONTRACT PHARMACAL
CIMETIDINE (CIMETIDINE) | ANDA #075122 | TABLET;ORAL | SANDOZ INC
CIMETIDINE (CIMETIDINE) | ANDA #075285 | TABLET;ORAL | L PERRIGO CO
CIMETIDINE (CIMETIDINE) | ANDA #075345 | TABLET;ORAL | IVAX SUB TEVA PHARMS
CIMETIDINE (CIMETIDINE) | ANDA #075425 | TABLET;ORAL | WATSON LABS TEVA
CIMETIDINE (CIMETIDINE) | ANDA #074316 | TABLET;ORAL | WATSON LABS INC
CIMETIDINE (CIMETIDINE) | ANDA #074329 | TABLET;ORAL | CHARTWELL MOLECULES
CIMETIDINE (CIMETIDINE) | ANDA #074151 | TABLET;ORAL | TEVA
CIMETIDINE (CIMETIDINE) | ANDA #074246 | TABLET;ORAL | MYLAN
CIMETIDINE (CIMETIDINE) | ANDA #074250 | TABLET;ORAL | SANDOZ INC
CIMETIDINE (CIMETIDINE) | ANDA #074100 | TABLET;ORAL | YAOPHARMA CO LTD
CIMETIDINE (CIMETIDINE) | ANDA #074566 | TABLET;ORAL | PLIVA
CIMETIDINE (CIMETIDINE) | ANDA #074568 | TABLET;ORAL | PLIVA
CIMETIDINE (CIMETIDINE) | ANDA #074361 | TABLET;ORAL | CYCLE PHARMS LTD
CIMETIDINE (CIMETIDINE) | ANDA #074463 | TABLET;ORAL | TEVA
CIMETIDINE (CIMETIDINE) | ANDA #074349 | TABLET;ORAL | WATSON LABS INC
CIMETIDINE (CIMETIDINE) | ANDA #074339 | TABLET;ORAL | DAVA PHARMS INC
CIMETIDINE (CIMETIDINE) | ANDA #074340 | TABLET;ORAL | DAVA PHARMS INC
CIMETIDINE (CIMETIDINE) | ANDA #074401 | TABLET;ORAL | IVAX SUB TEVA PHARMS
CIMETIDINE (CIMETIDINE) | ANDA #074402 | TABLET;ORAL | IVAX SUB TEVA PHARMS
CIMETIDINE (CIMETIDINE) | ANDA #074365 | TABLET;ORAL | TEVA
CIMETIDINE (CIMETIDINE) | ANDA #074371 | TABLET;ORAL | CYCLE PHARMS LTD
CIMETIDINE (CIMETIDINE) | ANDA #074506 | TABLET;ORAL | UPSHER SMITH LABS
CIMETIDINE (CIMETIDINE) | ANDA #074424 | TABLET;ORAL | IVAX SUB TEVA PHARMS
CIMETIDINE HYDROCHLORIDE (CIMETIDINE HYDROCHLORIDE) | ANDA #074428 | INJECTABLE;INJECTION | DAVA PHARMS INC
CIMETIDINE HYDROCHLORIDE (CIMETIDINE HYDROCHLORIDE) | ANDA #074344 | INJECTABLE;INJECTION | HOSPIRA
CIMETIDINE HYDROCHLORIDE (CIMETIDINE HYDROCHLORIDE) | ANDA #074345 | INJECTABLE;INJECTION | HOSPIRA
CIMETIDINE HYDROCHLORIDE (CIMETIDINE HYDROCHLORIDE) | ANDA #074353 | INJECTABLE;INJECTION | LUITPOLD
CIMETIDINE HYDROCHLORIDE (CIMETIDINE HYDROCHLORIDE) | ANDA #074412 | INJECTABLE;INJECTION | HOSPIRA
CIMETIDINE HYDROCHLORIDE (CIMETIDINE HYDROCHLORIDE) | ANDA #074422 | INJECTABLE;INJECTION | HOSPIRA
CIMETIDINE HYDROCHLORIDE (CIMETIDINE HYDROCHLORIDE) | ANDA #074541 | SOLUTION;ORAL | CYCLE PHARMS LTD
CIMETIDINE HYDROCHLORIDE (CIMETIDINE HYDROCHLORIDE) | ANDA #074553 | SOLUTION;ORAL | PHARM ASSOC
CIMETIDINE HYDROCHLORIDE (CIMETIDINE HYDROCHLORIDE) | ANDA #074610 | SOLUTION;ORAL | ANI PHARMS INC
CIMETIDINE HYDROCHLORIDE (CIMETIDINE HYDROCHLORIDE) | ANDA #074664 | SOLUTION;ORAL | HI TECH PHARMA
CIMETIDINE HYDROCHLORIDE (CIMETIDINE HYDROCHLORIDE) | ANDA #074005 | INJECTABLE;INJECTION | VINTAGE PHARMS LLC
CIMETIDINE HYDROCHLORIDE (CIMETIDINE HYDROCHLORIDE) | ANDA #074251 | SOLUTION;ORAL | LANNETT CO INC
CIMETIDINE HYDROCHLORIDE (CIMETIDINE HYDROCHLORIDE) | ANDA #074252 | INJECTABLE;INJECTION | TEVA PARENTERAL
CIMETIDINE HYDROCHLORIDE (CIMETIDINE HYDROCHLORIDE) | ANDA #074176 | SOLUTION;ORAL | G AND W LABS INC
CIMETIDINE HYDROCHLORIDE (CIMETIDINE HYDROCHLORIDE) | ANDA #074296 | INJECTABLE;INJECTION | HOSPIRA
CIMETIDINE HYDROCHLORIDE (CIMETIDINE HYDROCHLORIDE) | ANDA #075560 | SOLUTION;ORAL | PHARM ASSOC
CIMETIDINE HYDROCHLORIDE (CIMETIDINE HYDROCHLORIDE) | ANDA #075110 | SOLUTION;ORAL | ANI PHARMS INC
CIMETIDINE HYDROCHLORIDE (CIMETIDINE HYDROCHLORIDE) | ANDA #074757 | SOLUTION;ORAL | WOCKHARDT BIO AG
CIMETIDINE HYDROCHLORIDE (CIMETIDINE HYDROCHLORIDE) | ANDA #074859 | SOLUTION;ORAL | ANI PHARMS INC
CIMETIDINE HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (CIMETIDINE HYDROCHLORIDE) | ANDA #074269 | INJECTABLE;INJECTION | HOSPIRA
CIMETIDINE HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (CIMETIDINE HYDROCHLORIDE) | ANDA #074468 | INJECTABLE;INJECTION | HOSPIRA
PEPCID (FAMOTIDINE) | NDA #019462 | TABLET;ORAL | VALEANT PHARMS NORTH
PEPCID (FAMOTIDINE) | NDA #019510 | INJECTABLE;INJECTION | MERCK
PEPCID (FAMOTIDINE) | NDA #019527 | FOR SUSPENSION;ORAL | SALIX PHARMS
PEPCID AC (FAMOTIDINE) | NDA #020902 | TABLET;ORAL | J AND J CONSUMER INC
PEPCID AC (FAMOTIDINE) | NDA #020801 | TABLET, CHEWABLE;ORAL | J AND J CONSUMER INC
PEPCID AC (FAMOTIDINE) | NDA #020325 | TABLET;ORAL | J AND J CONSUMER INC
PEPCID COMPLETE (CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE) | NDA #020958 | TABLET, CHEWABLE;ORAL | J AND J CONSUMER INC
PEPCID PRESERVATIVE FREE (FAMOTIDINE) | NDA #019510 | INJECTABLE;INJECTION | MERCK
PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER (FAMOTIDINE) | NDA #020249 | INJECTABLE;INJECTION | MERCK SHARP DOHME
PEPCID RPD (FAMOTIDINE) | NDA #020752 | TABLET, ORALLY DISINTEGRATING;ORAL | MERCK
FAMOTIDINE (FAMOTIDINE) | ANDA #201695 | FOR SUSPENSION;ORAL | NOVEL LABS INC
FAMOTIDINE (FAMOTIDINE) | ANDA #201995 | FOR SUSPENSION;ORAL | HI-TECH PHARMA CO
FAMOTIDINE (FAMOTIDINE) | ANDA #206530 | TABLET;ORAL | AUROBINDO PHARMA LTD
FAMOTIDINE (FAMOTIDINE) | ANDA #206531 | TABLET;ORAL | AUROBINDO PHARMA LTD
FAMOTIDINE (FAMOTIDINE) | ANDA #077146 | TABLET;ORAL | WOCKHARDT
FAMOTIDINE (FAMOTIDINE) | ANDA #077351 | TABLET;ORAL | PERRIGO R AND D
FAMOTIDINE (FAMOTIDINE) | ANDA #077352 | TABLET;ORAL | PERRIGO R AND D
FAMOTIDINE (FAMOTIDINE) | ANDA #077367 | TABLET;ORAL | DR REDDYS LABS LTD
FAMOTIDINE (FAMOTIDINE) | ANDA #075942 | INJECTABLE;INJECTION | APOTEX INC
FAMOTIDINE (FAMOTIDINE) | ANDA #076101 | TABLET;ORAL | SANDOZ
FAMOTIDINE (FAMOTIDINE) | ANDA #078641 | INJECTABLE;INJECTION | MYLAN LABS LTD
FAMOTIDINE (FAMOTIDINE) | ANDA #078916 | TABLET;ORAL | ALEMBIC PHARMS LTD
FAMOTIDINE (FAMOTIDINE) | ANDA #091020 | FOR SUSPENSION;ORAL | NAVINTA LLC
FAMOTIDINE (FAMOTIDINE) | ANDA #090283 | TABLET;ORAL | SUN PHARM INDS LTD
FAMOTIDINE (FAMOTIDINE) | ANDA #090837 | TABLET;ORAL | WOCKHARDT
FAMOTIDINE (FAMOTIDINE) | ANDA #090440 | FOR SUSPENSION;ORAL | LUPIN LTD
FAMOTIDINE (FAMOTIDINE) | ANDA #075062 | TABLET;ORAL | WATSON LABS
FAMOTIDINE (FAMOTIDINE) | ANDA #075192 | INJECTABLE; INJECTION | MARSAM PHARMS LLC
FAMOTIDINE (FAMOTIDINE) | ANDA #075193 | INJECTABLE; INJECTION | MARSAM PHARMS LLC
FAMOTIDINE (FAMOTIDINE) | ANDA #075194 | INJECTABLE; INJECTION | MARSAM PHARMS LLC
FAMOTIDINE (FAMOTIDINE) | ANDA #075302 | TABLET;ORAL | PLD ACQUISITIONS
FAMOTIDINE (FAMOTIDINE) | ANDA #075311 | TABLET;ORAL | TEVA
FAMOTIDINE (FAMOTIDINE) | ANDA #075312 | TABLET;ORAL | TEVA
FAMOTIDINE (FAMOTIDINE) | ANDA #075400 | TABLET;ORAL | PERRIGO
FAMOTIDINE (FAMOTIDINE) | ANDA #075404 | TABLET;ORAL | WATSON LABS
FAMOTIDINE (FAMOTIDINE) | ANDA #075457 | TABLET;ORAL | MYLAN PHARMS INC
FAMOTIDINE (FAMOTIDINE) | ANDA #075511 | TABLET;ORAL | IVAX SUB TEVA PHARMS
FAMOTIDINE (FAMOTIDINE) | ANDA #075512 | TABLET;ORAL | P AND L
FAMOTIDINE (FAMOTIDINE) | ANDA #075607 | TABLET;ORAL | SANDOZ
FAMOTIDINE (FAMOTIDINE) | ANDA #075610 | TABLET;ORAL | APOTEX
FAMOTIDINE (FAMOTIDINE) | ANDA #075611 | TABLET;ORAL | APOTEX
FAMOTIDINE (FAMOTIDINE) | ANDA #075639 | TABLET;ORAL | SUN PHARM INDUSTRIES
FAMOTIDINE (FAMOTIDINE) | ANDA #075650 | TABLET;ORAL | ACTAVIS ELIZABETH
FAMOTIDINE (FAMOTIDINE) | ANDA #075651 | INJECTABLE;INJECTION | ATHENEX INC
FAMOTIDINE (FAMOTIDINE) | ANDA #075488 | INJECTABLE;INJECTION | WEST-WARD PHARMS INT
FAMOTIDINE (FAMOTIDINE) | ANDA #075674 | TABLET;ORAL | MYLAN
FAMOTIDINE (FAMOTIDINE) | ANDA #075684 | INJECTABLE;INJECTION | ATHENEX INC
FAMOTIDINE (FAMOTIDINE) | ANDA #075704 | TABLET;ORAL | MYLAN
FAMOTIDINE (FAMOTIDINE) | ANDA #075705 | INJECTABLE;INJECTION | HOSPIRA
FAMOTIDINE (FAMOTIDINE) | ANDA #075707 | INJECTABLE;INJECTION | APOTHECON
FAMOTIDINE (FAMOTIDINE) | ANDA #075709 | INJECTABLE;INJECTION | FRESENIUS KABI USA
FAMOTIDINE (FAMOTIDINE) | ANDA #075715 | TABLET, CHEWABLE;ORAL | PERRIGO
FAMOTIDINE (FAMOTIDINE) | ANDA #075718 | TABLET;ORAL | DR REDDYS LABS LTD
FAMOTIDINE (FAMOTIDINE) | ANDA #075793 | TABLET;ORAL | SANDOZ
FAMOTIDINE (FAMOTIDINE) | ANDA #075799 | INJECTABLE;INJECTION | WEST-WARD PHARMS INT
FAMOTIDINE (FAMOTIDINE) | ANDA #075805 | TABLET;ORAL | CARLSBAD
FAMOTIDINE (FAMOTIDINE) | ANDA #075786 | TABLET;ORAL | CELLTRION
FAMOTIDINE (FAMOTIDINE) | ANDA #075870 | INJECTABLE;INJECTION | HOSPIRA
FAMOTIDINE (FAMOTIDINE) | ANDA #075905 | INJECTABLE;INJECTION | HOSPIRA
FAMOTIDINE PRESERVATIVE FREE (FAMOTIDINE) | ANDA #075813 | INJECTABLE;INJECTION | FRESENIUS KABI USA
FAMOTIDINE PRESERVATIVE FREE (FAMOTIDINE) | ANDA #075825 | INJECTABLE;INJECTION | ATHENEX INC
FAMOTIDINE PRESERVATIVE FREE (FAMOTIDINE) | ANDA #075708 | INJECTABLE;INJECTION | APOTHECON
FAMOTIDINE PRESERVATIVE FREE (FAMOTIDINE) | ANDA #075669 | INJECTABLE;INJECTION | HOSPIRA
FAMOTIDINE PRESERVATIVE FREE (FAMOTIDINE) | ANDA #075622 | INJECTABLE;INJECTION | ATHENEX INC
FAMOTIDINE PRESERVATIVE FREE (FAMOTIDINE) | ANDA #075486 | INJECTABLE;INJECTION | WEST-WARD PHARMS INT
FAMOTIDINE PRESERVATIVE FREE (FAMOTIDINE) | ANDA #078642 | INJECTABLE;INJECTION | MYLAN LABS LTD
FAMOTIDINE PRESERVATIVE FREE (FAMOTIDINE) | ANDA #075789 | INJECTABLE;INJECTION | WEST-WARD PHARMS INT
FAMOTIDINE PRESERVATIVE FREE (FAMOTIDINE) | ANDA #076324 | INJECTABLE;INJECTION | APOTEX INC
FAMOTIDINE PRESERVATIVE FREE (PHARMACY BULK) (FAMOTIDINE) | ANDA #076322 | INJECTABLE;INJECTION | APOTEX INC
FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER (FAMOTIDINE) | ANDA #075591 | INJECTABLE;INJECTION | BAXTER HLTHCARE
FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER (FAMOTIDINE) | ANDA #075729 | INJECTABLE;INJECTION | ABBVIE
FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE (CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE) | ANDA #077355 | TABLET, CHEWABLE;ORAL | PERRIGO R AND D
FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE (CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE) | ANDA #204782 | TABLET, CHEWABLE;ORAL | PERRIGO R AND D

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Zantac MDL Established in Southern District of Florida (West Palm Beach) Over Cancer-Causing Impurity NDMA

A panel of federal judges consolidated 126 lawsuits over a cancer-causing impurity in the heartburn medication Zantac before the federal court in West Palm Beach, FL. Plaintiffs in all the actions allege that Zantac—and its active ingredient ranitidine—breaks down to form a carcinogen known as N-Nitrosodimethylamine (NDMA).

NDMA is classified as a probable human carcinogen based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.

The Plaintiffs have cancer of the bladder, kidney, colon, and stomach, and they charge that the manufacturers, sellers, and distributors of Zantac and other Ranitidine medications knew or should have known that these medications exposed consumers to NDMA, and that defendants concealed the NDMA-associated dangers posed to consumers.

The defendants include Boehringer Ingelheim Pharmaceuticals, Inc.; GlaxoSmithKline LLC; Pfizer Inc.; Sanofi-Aventis U.S. LLC; Sanofi US Services Inc.; and Chattem, Inc.

US District Judge Robin L. Rosenberg will preside over the new MDL No. 2924. The JPMDL transfer order can be found here.

The Judicial Panel for Multidistrict Litigation ruled that all the cases involve common questions of fact:

  • How Ranitidine forms NDMA.
  • The nature and extent of the health risks posed by NDMA and the NDMA levels at issue.
  • Defendants’ knowledge of the NDMA-associated risks of Ranitidine.
  • The impact of any findings made by the U.S. Food and Drug Administration, which is investigating this issue.

The Food and Drug Administration is investigating why NDMA is turning up in drugs used to control high blood sugar in patients with type 2 diabetes, in prescription antacids like Zantac and in Valsartan and Losartan, which treat high blood pressure and heart failure.

Glenmark Pharmaceutical Inc., USA announced on December 17, 2019, the voluntary recall of all unexpired lots of Ranitidine (Zantac) Tablets, 150 mg and 300 mg, to the consumer level. Zantac provides heartburn relief for acid in the stomach and has been sold in the US for more than 30 years.

Also recalling Ranitidine products are Appco Pharma LLC, Aurobindo Pharma USA, Sanofi, GlaxoSmithKline, Novartis, Dr. Reddy’s Laboratories, Perrigo, Novitium Pharma, and Lannett Company.

Research by supplement company Valisure, titled Valisure Detects NDMA in Ranitidine, “found that NDMA was the result of the; ‘inherent instability’ of the Ranitidine molecule. This means that all manufacturers, brand or generic, and all lots of Ranitidine-containing medications are affected and could generate high levels of NDMA in the human body.”

In a 2016 study on oral intake of Ranitidine, scientists examined urine samples from five female and five male healthy volunteers over 24-hour periods before and after consumption of 150 mg of Ranitidine. Following intake, the urinary NDMA excreted over 24 hours increased 400-fold from 110 to 47,600 ng, while total N-nitrosamines increased by 5-fold.

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