Xtampza ER Approval History
FDA Approved: Yes (First approved April 26, 2016)
Brand name: Xtampza ER
Generic name: oxycodone
Dosage form: Extended-Release Capsules
Company: Collegium Pharmaceutical, Inc.
Treatment for: Chronic Pain
Xtampza ER (oxycodone) is an extended-release, abuse-deterrent, narcotic analgesic for the treatment of chronic pain.
Development History and FDA Approval Process for Xtampza ER
|Apr 26, 2016|| Collegium Receives FDA Approval for Xtampza ER, an Analgesic with Abuse-Deterrent Properties|
|Nov 9, 2015||Collegium Announces FDA Tentative Approval for Xtampza ER, a Novel Abuse-Deterrent Analgesic for Chronic Pain|
|Oct 12, 2015||Collegium Provides Update on FDA Review of Xtampza ER, an Abuse-Deterrent Analgesic for the Treatment of Chronic Pain|
|Sep 11, 2015||Collegium Announces FDA Advisory Committees Unanimously Recommend Approval of Xtampza ER, an Abuse-Deterrent Analgesic for Chronic Pain|
|Aug 7, 2015||Collegium Announces FDA Advisory Committee Meeting for Xtampza ER, an Abuse-Deterrent Analgesic for Chronic Pain|
|Feb 12, 2015||Collegium Announces FDA Acceptance for Filing of NDA for Abuse-Deterrent Xtampza ER (oxycodone)|
|Dec 15, 2014||Collegium Pharmaceutical Submits NDA for Xtampza ER (oxycodone) Abuse-Deterrent Analgesic|
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