FDA Rebuffs Novartis Pharma AG Over Delay To Biogeneric Drug

The U.S. Food and Drug Administration has asked a U.S. court to dismiss a lawsuit from a unit of Novartis AG alleging undue regulatory delays in deciding on its copycat human growth hormone drug, Omnitrope. Sandoz, the generics arm of the Swiss drug maker, sued the agency in September for leaving the product in limbo -- in a move designed to break a logjam over so-called biogenerics. The FDA argued in its defence that the charges were unfounded, since its experts had not finished their review. In its response filed in the U.S. District Court in Washington this week, the FDA admitted that it did not request additional information for Omnitrope's new drug application but denied that its professional scientific and review staff had completed their review of the application. The FDA did not disclose any reason why the application should be either approved or rejected. Sandoz said in a statement it remained confident of an eventual positive decision.

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