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FDA Accepts NuPathe's Zelrix NDA For Filing - Quick Facts

By RTTNews Staff Writer   ✉   | Published:   | Follow Us On Google News
rttnewslogo20mar2024

NuPathe Inc. (PATH) said its NDA for Zelrix has been accepted for filing by the U.S. Food and Drug Administration. NuPathe submitted the Zelrix NDA on October 29, 2010.

The company expects to receive a Prescription Drug User Fee Act date, the target date for the FDA to complete its review of the NDA, of August 29, 2011.

Zelrix is the first ever submission to the FDA of a transdermal patch for the treatment of migraine.

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