Sunday, April 8, 2007

FDA Requests Certain Nausea Drugs Not Be Marketed

Article in the Wall Street Journal -- FDA Targets Unapproved Nausea Drugs, by Jennifer Corbett Dooren.  Here's an excerpt:

The U.S. Food and Drug Administration said Friday that it was asking manufacturers of a certain type of drug to treat nausea and vomiting to stop making and marketing the products.

Specifically, the FDA is asking manufacturers of suppository drug products that contain trimethobenzamide hydrochloride to stop making them because they are not FDA-approved.

The action is part of an ongoing agency effort to go after prescription drugs that do not have FDA approval. Many of the unapproved drugs were on the market before a 1962 law that requires the FDA to evaluate a drug's effectiveness and safety before allowing it on the market. Prior laws required the agency to look mostly at safety.

Deborah Autor, the director of FDA's office of compliance, said the agency estimates there are "hundreds" of prescription drugs on the U.S. market that lack FDA approval.

BGS

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