Generics

Company gets final FDA approval for fenofibrate capsules ANDA

Published in Medical Letter on the CDC and FDA, November 30th, 2003

IMPAX Laboratories, Inc., (IPXL) announced that the U.S. Food and Drug Administration (FDA) has granted approval to the company's abbreviated new drug application for a generic version of fenofibrate capsules, micronized.

Tricor (fenofibrate capsules) micronized was formerly marketed by Abbott Laboratories, Inc., (ABT) for the treatment of very high serum triglyceride levels.

Abbott has previously discontinued sales of the capsule form and has replaced it in the market with a tablet formulation.

IMPAX currently has 17 applications pending at the FDA, including 3 tentatively approved, which address approximately $7 billion in U.S....

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Source: Medical Letter on the CDC and FDA (2003-11-30)

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