Collegium Provides Update on FDA Review of Xtampza(TM) ER, an Abuse-Deterrent Analgesic for the Treatment of Chronic Pain
Collegium Pharmaceutical, Inc. (Nasdaq: COLL) today announced that the U.S. Food and Drug Administration (FDA) has advised Collegium that it will not be able to complete its review of the New Drug Application (NDA) for Xtampza™ ER (oxycodone) extended-release capsules by the Prescription Drug User Fee Act (PDUFA) action date of October 12, 2015.
"We are confident in the Xtampza ER program and our NDA submission. We continue to work closely with the FDA as they complete their review," said Michael Heffernan, Collegium's Chairman and CEO. "We look forward to bringing Xtampza ER to market as a potential novel treatment option for patients in need of chronic pain therapy."
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