FDA Ruling Blocking Celebrex Generics Reversed in Mylan Win
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A U.S. appeals court reversed a Food and Drug Administration ruling that effectively blocked until June Mylan Pharmaceuticals Inc., Watson Laboratories Inc. and Lupin Pharmaceuticals Inc. from selling generic versions of the arthritis drug Celebrex, paving the way for low-cost alternatives.
The law governing versions of Celebrex, which generates $3 billion in sales annually for Pfizer Inc., is “unambiguous” in favor of generics, the U.S. Court of Appeals in Richmond, Virginia, said in a ruling today.