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FDA defers Omnitrope decision

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA notifies Sandoz Aug. 31 that "the agency is unable to reach a decision on whether to approve" the firm's recombinant human growth hormone Omnitrope. Sandoz is presenting the decision essentially as a tentative approval for the follow-on biologic to Pfizer's Genotropin. "According to the FDA letter…the agency has completed its review of Omnitrope and did not identify any deficiencies in the application," Sandoz says. However, FDA could not reach a final decision "due to uncertainty regarding scientific and legal issues." Sandoz acknowledges that approval of most follow-on biologics will require new legislation. Pfizer previously petitioned FDA not to approve the Omnitrope 505(b)(2) NDA on the grounds that it improperly relies on proprietary information...
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