FDA Holds Off On Biogenerics Decision

Law360, New York (September 7, 2004, 12:00 AM EDT) -- In a case widely seen as a litmus test for biogenerics, the U.S. Food and Drug Administration has deferred approval of a generic recombinant DNA human growth hormone that pharmaceutical giant Novartis AG wants to market as Omnitrope.

Sandoz, Novartis’ generics unit, said last week 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.

“We appreciate the constructive consultations held with the agency, and...
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