FDA Rejects Watson Bioequivalency Claims to Block Generic

The FDA has categorically turned down Watson Pharmaceuticals’ attempt to block Sandoz from producing a generic version of its prostate drug Rapaflo. The Actavis subsidiary filed a citizen petition earlier this year asking the FDA to throw out a Paragraph IV ANDA submission by Sandoz for a Rapaflo (silodosin) copycat, claiming its bioequivalency requirements were not sufficiently stringent, which could result in patients being over-dosed or under-dosed.
Drug Industry Daily