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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

DateArticle
Apr 26, 2016Approval Collegium Receives FDA Approval for Xtampza ER, an Analgesic with Abuse-Deterrent Properties
Nov  9, 2015Collegium Announces FDA Tentative Approval for Xtampza ER, a Novel Abuse-Deterrent Analgesic for Chronic Pain
Oct 12, 2015Collegium Provides Update on FDA Review of Xtampza ER, an Abuse-Deterrent Analgesic for the Treatment of Chronic Pain
Sep 11, 2015Collegium Announces FDA Advisory Committees Unanimously Recommend Approval of Xtampza ER, an Abuse-Deterrent Analgesic for Chronic Pain
Aug  7, 2015Collegium Announces FDA Advisory Committee Meeting for Xtampza ER, an Abuse-Deterrent Analgesic for Chronic Pain
Feb 12, 2015Collegium Announces FDA Acceptance for Filing of NDA for Abuse-Deterrent Xtampza ER (oxycodone)
Dec 15, 2014Collegium Pharmaceutical Submits NDA for Xtampza ER (oxycodone) Abuse-Deterrent Analgesic

Further information

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