Glenmark Generics and Konec Inc. to Stop Marketing Unapproved Nitroglycerin Tablets

  • Date: March 17, 2010
  • Source: Admin
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Unapproved Drug Labeling

The Nitroglycerin tablets, produced by the alleged companies are used by the patients to get relieved chest pain or to stop a heart attack and they are supposed to be placed under the tongue for immediate action. The tablets are and are available in 0.3 mg, 0.4 mg, and 0.6 mg dosages.

As FDA did not review the quality and labeling of these products, it believes that these Nitroglycerin tablets can be prove to be harmful. However, keeping in mind the past records of unapproved Nitroglycerin tablets, FDA suggests using FDA approved tablets of Pfizer Inc. which is available in the same strengths and is able to supply the market with approved products. Apart from the patients, FDA is trying to inform the health care organizations and health care professionals to use only the approved Nitroglycerin tablets.

Deborah M. Autor, director of the Office of Compliance at the FDA’s Center for Drug Evaluation and Research (CDER) says ““Doctors and patients should know that not all drugs on the market are backed by an FDA approval… This lack of approval undermines the FDA’s efforts to ensure that safe and effective drug products are available to the American public.”

According to CDER Director Janet Woodcock, M.D. “Consumers are entitled to know that their drugs meet FDA standards, and it is a priority for the agency to remove from the market unapproved products that expose consumers to potentially unsafe, ineffective, or poor quality drugs".

FDA’s Till Date Initiatives

In June 2006, a new drug safety initiative was announced by FDA, aim of which was to remove unapproved drugs from the market. A final guidance titled Marketed Unapproved Drugs—Compliance Policy Guide (CPG, available at www.fda. gov/cder/guidance/6911fnl.pdf)had been included in that initiative in order to outline enforcement policies which aimed at efficiently and rationally bringing all unapproved drugs into the approval process. For all unapproved drugs, the CPG gives highest enforcement priority to the following:

  • Drugs with potential safety risks
  • Drugs that lack evidence of effectiveness
  • Health fraud drugs
  • Drugs that present direct challenges to the new drug approval and OTC drug monograph systems
  • Unapproved new drugs those are also violative of the Act in other ways
  • Drugs that are reformulated to evade an FDA enforcement action

Summary of Compliance Policy Guide

The Marketed Unapproved Drugs—Compliance Policy Guide (CPG):

- Provides official notice that any illegally marketed product is subject to FDA enforcement at any time

- Clarifies that the FDA intends to use a risk-based approach to enforcement

- Once the risk-based assessment has been made, the FDA can and will take any number of enforcement actions, including but not limited to:

  • Requesting voluntary compliance
  • Providing notice of action in a Federal register notice
  • Issuing an untitled letter
  • Issuing a warning letter, or
  • Initiating a seizure, injunction, or other proceeding

Impact of Warning

FDA has given a deadline of 15 days to respond to the FDA with a plan for removing their products from the market. They have 90 days from the date of the warning letters to stop manufacturing new products and 180 days to stop further shipment of existing products.



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