Exenatide Once Weekly New Drug Application Review Extended By FDA Due To Weather-Related Closure

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Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) confirmed that the U.S. Food and Drug Administration (FDA) has set a new Prescription Drug User Fee Act (PDUFA) accomplish escort of March 12 for its inspection of the exenatide erst hebdomadary new dose covering (NDA). The revised activeness appointment is the outcome of the FDA’s determination to let cinque extra years for its reassessment of pending regulative applications pursuit the office’s late five-day weather-related closing.

Exenatide formerly hebdomadal is an investigational, extended-release medicament for character 2 diabetes intentional to return uninterrupted curative levels of exenatide in a one hebdomadary elvis. The NDA for exenatide erstwhile hebdomadal was submitted in May 2009 and recognized by the FDA in July 2009.

Additional data some weather-related delays is useable in a imperativeness dismissal on the FDA’s Web website.

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