Sandoz Files Lawsuit Seeking FDA Ruling on Omnitrope

16-Sep-2005

Sandoz announced that it has filed a lawsuit against the US Food and Drug Administration, seeking a ruling on its pending new drug application for the human growth hormone Omnitrope.

"We believe it is important for patients and health-care providers that cost-effective follow-on protein products like Omnitrope become available as safe and effective, but less expensive and equivalent therapeutic alternatives," said Andreas Rummelt, CEO of Sandoz. "Having already acknowledged the sound science behind this application, the FDA should approve Omnitrope."

Under both the Federal Food Drug and Cosmetic Act and the Food Prescription Drug User Fee Act, the FDA is required to either approve or reject new drug applications. Sandoz filed its application for Omnitrope in July 2003. On September 2, 2004, Sandoz announced that FDA had notified the company that the Agency was unable to reach a decision on whether to approve the company's application for Omnitrope. No action on the application has been taken since then.

The lawsuit, filed in US District Court for the District of Columbia, seeks to reverse the Agency's failure to act on the Omnitrope application in accordance with the Commissioner's statutory obligations.

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