FDA Approves First Generic Equivalent of Treatment for Hypertension and Angina

January 06, 2000

New York (MedscapeWire) Jan 6 — The Food and Drug Administration (FDA) has granted final approval for the first AB-ratedgeneric version of Pfizer Inc's Procardia XL (nifedipine), one of the largest selling drugs for hypertension and angina. The AB designation by the FDA, a certification of bioequivalence, allows pharmacies to substitute this generic version when a physician prescribes Procardia XL. The generic drug has been approved for a 30-mg dose.

"The application for the generic nifedipine has now been cleared from a regulatory perspective," said Tod R. Hamachek, chairman and chief executive officer of Penwest Pharmaceuticals, comanufacturer of the drug along with Mylan Pharmaceuticals. "Mylan will now decide when this product will be marketed. Since Mylan was the first to file with the FDA and challenge the enforceability and assert the noninfringement of a listed patent, Penwest expects that the 30-mg product will have a minimum of 180 days of generic market exclusivity after final approval by the FDA."

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