FDA Grants Priority Review To New Drug Application For MNK-795

New Drug Approvals

FDA Grants Priority Review To New Drug Application For MNK-795 Submitted By Depomed Licensee Mallinckrodt

Controlled Substance Analgesic Combination Product Uses Depomed’s Proprietary Acuform® Technology

NEWARK, Calif., July 29, 2013 /PRNewswire/ — Depomed, Inc. (NASDAQ:DEPO) announced today that the U. S. Food and Drug Administration (FDA) has accepted for filing a New Drug Application (NDA) from Mallinckrodt (NYSE: MNK) for MNK-795.  MNK-795 is a controlled-release oral formulation of oxycodone and acetaminophen that has been studied for the management of moderate to severe acute pain where the use of an opioid analgesic is appropriate.  MNK-795 is formulated with Depomed’s Acuform® drug delivery technology.

 

http://www.pharmalive.com/fda-grants-priority-review-to-new-drug-application-for-mnk-795

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