Thursday, April 08, 2010 10:27:59 PM
FDA SVNT Sept 14 2010
Savient Pharmaceuticals (SVNT)
Drug/indication: Krystexxa for gout
Approval decision date: Sept. 14
The FDA refused to approve Krystexxa last August, citing problems with the way the drug is manufactured. Savient revised the Krystexxa manufacturing process and submitted a response in March to the FDA's complete response letter.
Savient Pharmaceuticals (SVNT)
Drug/indication: Krystexxa for gout
Approval decision date: Sept. 14
The FDA refused to approve Krystexxa last August, citing problems with the way the drug is manufactured. Savient revised the Krystexxa manufacturing process and submitted a response in March to the FDA's complete response letter.
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