Xtampza ER FDA Approval History
Last updated by Judith Stewart, BPharm on Feb 2, 2021.
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 timeline for Xtampza ER
| Date | Article |
|---|
| Apr 26, 2016 | Approval 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 |
Further information
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