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FDA Orders Two Firms to Stop Making Unapproved Nitroglycerin

Mar 29, 2010 | Parker Waichman LLP

Generic drug makers Konec Inc. and Glenmark Generics Inc. have apparently been marketing unapproved nitroglycerin tablets for years.  While the Food & Drug Administration (FDA) recently ordered both firms to stop doing so,  the drug continues to be sold in pharmacies while the Food & Drug Administration’s (FDA) order takes effect.

Nitroglycerin tablets are placed under the tongue to reduce chest pain in angina or to stop a heart attack. Taking an ineffective or defective nitroglycerin tablet could cause angina to progress to a heart attack.

Unfortunately, heart patients often have varied responses to nitroglycerin tablets, so it will likely be impossible to determine if any of these pills caused any adverse effects, the New York Times said. The FDA said that it had not examined the quality of the products it was ordering off the market but that it had recorded problems with other unapproved nitroglycerin products in the past.

At least four million prescriptions – close to 80% of all those written – were filled last year for nitroglycerin tablets that were not approved by the FDA. Drug makers like Konec and Glenmark have marketed unapproved drugs for years, claiming they were grandfathered in when the FDA was established in 1938. However, the FDA disputes this interpretation. According The New York Times, the agency has recently been cracking down on such drugs.

On March 16, the agency sent warning letters to Konec and Glenmark  ordering them to stop producing nitroglycerin tablets within 90 days, although they can continue to ship them for another six months.

The FDA has not asked Konec or Glenmark to recall the unapproved nitroglycerin tablets. According to The New York Times, some major pharmacies, including CVS and Walgreens, plan to continue selling the drugs because the FDA warning letter stipulated that the nitroglycerin could continue to be shipped for another six months.

Nitrostat, made by Pfizer, is the only nitroglycerin pill currently on the market that has FDA approval. Pfizer has stepped up production and expects to be able to meet the entire U.S. demand for nitroglycerin tablets.

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