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Cadence Pharma Reveals Priority Review And Acceptance Of NDA Submission For Acetavance For Treatment Of Acute Pain And Fever - Quick Facts

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

Cadence Pharmaceuticals Inc. (CADX) announced that its New Drug Application or NDA for Acetavance (intravenous acetaminophen), its investigational product candidate for the treatment of acute pain and fever in adults and children, has been accepted for filing by the U.S. Food and Drug Administration and designated for Priority Review.

The FDA has issued an action date for the NDA of November 13, 2009 under the Prescription Drug User Fee Act (PDUFA).

The Priority Review designation reduces the target review period for the NDA from ten months to six months.

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