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FDA generic user fees moving closer to reality
ROCKVILLE, Md. — A backlog of more than 2,000 drug entities and devices is awaiting approval. That’s the situation facing the Food and Drug Administration and the generic pharmaceutical industry—and it’s the chief impetus behind the FDA’s push to impose user fees on generic drug makers seeking the agency’s review and approval for their brand-equivalent medicines.
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Countdown to 2011: A big year for generics
The world of generic drugs has a big year ahead of it. Actually, it has a few big years ahead of it. But 2011 in particular carries a certain symbolic value as the year in which Pfizer, the world’s biggest drug maker, loses control of its patent for the cholesterol-lowering drug Lipitor (atorvastatin calcium), the world’s top-selling drug.