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FDA orders halt on unapproved tablets

The US Food and Drug Administration (FDA) has ordered two companies to stop the marketing of unapproved nitroglycerine tablets

The US Food and Drug Administration (FDA) has ordered two companies to stop the marketing of unapproved nitroglycerine tablets.

Konec Inc. and Glenmark Generics, both based in the US, were ordered to remove their chest pain relief drugs as part of the FDA's Unapproved Drugs Initiative. The initiative was set up in 2006 to tackle drugs on the market that had not been approved by the FDA.

The FDA has said it is concerned that "unapproved sublingual nitroglycerin tablets are not proven safe and effective" and that such unapproved drugs have been known to have "significant quality and efficacy problems".

"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," said Dr Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research (CDER). "The FDA remains committed to ensuring that prescription drugs obtain the necessary FDA approval, and we urge companies to actively pursue such approvals."

Although the drugs will not be recalled, the FDA has sent warning letters to both Glenmark and Konec, with each company having 15 days to respond with a discontinuation plan for their products. They have 90 days from the date of the warning letters to cease manufacturing new products and 180 days to cease further shipment of existing products.

Previously manufactured unapproved products affected by this action may still be found on pharmacy shelves for a short period of time.

The FDA has said it "does not anticipate a supply problem for these products" with Pfizer's sublingual nitroglycerin tablets approved by the FDA and able to supply the market.

The agency also advised consumers using the unapproved products to continue taking their medication and consult a health care professional for guidance on alternative treatment options.

17th March 2010

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