Food & Drug Law Weekly
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Generic Drugs
Agency defers approval decision for Omnitrope
September 24th, 2004
The U.S. Food and Drug Administration (FDA) has deferred approval of a generic recombinant DNA human growth hormone that pharmaceutical giant Novartis AG wants to market as Omnitrope. Sandoz, the Novartis division seeking approval of the drug, said it received a letter from the FDA saying the agency found no deficiencies in its application. However, the agency added "uncertainty regarding scientific and legal issues" prompted it to delay action. The company "submitted complete and thorough data to support marketing approval for Omnitrope," Alexander Berghout, MD, Sandoz's head of biopharmaceutical clinical development and regulatory affairs, said in...
Source: Food & Drug Law Weekly (2004-09-24)
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