FDA To Review Approval Of Norvasc Generic As 505 (b) (2) Gateway Is Tested In Court

Law360, New York (February 9, 2004, 12:00 AM EST) -- In a move that could have broad ramifications for 505 (b) (2) generic drug approvals, the U.S. Food and Drug Administration has stayed its decision to allow Indian drug maker Dr. Reddy's Laboratories to market a generic version of Pfizer’s anti-hypertension drug Norvasc.

The FDA made the decision pending a court verdict following hearings last July in which Pfizer challenged Dr. Reddy's right to market the drug. The FDA’s letter indicated the re-evaluation was prompted by questions raised about the source of the data relied on...
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