Wednesday, April 14, 2010

Nitroglycerine Update


Majority of nitroglycerin tablets not approved by FDA.

The New York Times (3/27, B1, Singer) reported that most nitroglycerin tablets prescribed by US physicians are not approved by the FDA. Last week, the FDA "sent warning letters...to two drugmakers ordering them to stop marketing unapproved nitroglycerin tablets." The agency "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." Michael Levy, a division director in the FDA's Center for Drug Evaluation and Research, said, "Pharmacies likely mistake them for generic drugs or for drugs likely to be grandfathered, neither of which is the case."
FDA website can help consumers find all approved drugs. The New York Times (3/27, B2, Singer) reported, "If consumers want to know for sure whether the drugs that pharmacists are using to fill their prescriptions have been approved by the Food and Drug Administration, they can check the FDA's website." The agency's website includes "both an online database of approved drugs, called drugs@fda, as well as an electronic catalog of approved drugs, called the Orange Book," where "people can look up medications by the brand name or active ingredient." The Times adds, "As many as 2 percent of the prescriptions dispensed in the United States may be for drugs that the F.D.A. has not formally approved, the agency estimates."

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