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Home » TRUE, AUTHORIZED GENERICS THE SAME, MYLAN SAYS IN SUIT AGAINST FDA
TRUE, AUTHORIZED GENERICS THE SAME, MYLAN SAYS IN SUIT AGAINST FDA
August 24, 2004
The FDA has abandoned its own precedent that authorized generics are functionally and legally equivalent to true generics, Mylan Pharmaceuticals argues in a lawsuit that alleges the agency improperly allowed a brand-authorized generic to launch during Mylan’s generic marketing exclusivity period for the same drug.