Generic Drug Approvals

Generic Drug Approvals. First-Time Generic Approvals. Mobic, Propecia, Zithromax

New Initiative to Improve Availability of Generics: “Bioequivalence” required


October 15th, 2008 by admin


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Makers of generic drugs are not required to repeat the extensive clinical trials that have already been used in the development of the original drug, says Buehler. “But they must scientifically demonstrate that their product is bioequivalent. This means that it performs in the same way as the brand-name drug.”

In the United States, trademark laws do not allow generic drugs to look exactly like the brand-name drug. Thus, colors, flavors, and certain other characteristics may be different. “But these differences don’t affect the way the drugs work or the way they are evaluated by FDA,” says Buehler. “The generic drug must have the same active ingredients.”

Consumers and their health care providers should decide whether it is best to use the brand-name or generic version of a medicine. In addition, consumers should always ask whether they are being prescribed a generic or brand-name drug, and why that particular drug was prescribed.

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