FDA Approval Expected to Set Off Legal Battle

Law360, New York (November 5, 2003, 12:00 AM EST) -- In a move likely to set off a tidal wave of litigation, the U.S. Food and Drug Administration approved a generic version of Pfizer's hypertension medication Norvasc by Indian generics maker Dr. Reddy's Laboratories Ltd. through a hotly disputed approval pathway, the Wall Street Journal reported Wednesday.

Dr. Reddy's received the approval through the controversial 505(b)(2) drug application approval for generics, which allows drugmakers to use clinical data from other, similar drugs for their own new drug applications without subjecting the new product to the same...
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