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Article: FDA widens probe of generic drug bioequivalence. (Food and Drug Administration)
- Article from:
- Chain Drug Review
- Article date:
- September 11, 1989
CopyrightCOPYRIGHT 1989 Racher Press, Inc. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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FDA widens probe of generic drug bioequivalence
NEW YORK--The Food and Drug Administration's probe of the generic drug industry has widened, as the agency proposed to withdraw approval for Bolar Pharmaceuticals' generic version of Diazide.
Bolar, which has 30 days to respond to the ruling, says it will proceed with a new biostudy to regain approval for the antihypertension drug, even though that may take a year. In the meantime, the company says the drug will remain on the market. A company spokesman says that, at least for now, it will also accept the FDA's decision to downgrade the drug's classification to BX, which assumes it is not bioequivalent.
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