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Troxyca ER Approval History

FDA Approved: Yes (Discontinued) (First approved August 19, 2016)
Brand name: Troxyca ER
Generic name: naltrexone and oxycodone
Dosage form: Extended-Release Capsules
Company: Pfizer Inc.
Treatment for: Pain

Marketing Status: Discontinued

Troxyca ER (oxycodone hydrochloride and naltrexone hydrochloride) is an extended-release, abuse-deterrent, narcotic analgesic formulation for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment.

Development History and FDA Approval Process for Troxyca ER

DateArticle
Aug 19, 2016Approval FDA Approves Troxyca ER (oxycodone hydrochloride and naltrexone hydrochloride) Capsules with Abuse-Deterrent Properties for the Management of Pain
Jun  8, 2016Pfizer Announces FDA Advisory Committees’ Recommend ALO-02 (oxycodone hydrochloride and naltrexone hydrochloride) Extended-Release Capsules for Approval
Feb 13, 2015Pfizer Announces FDA Acceptance for Review of NDA for ALO-02 (oxycodone hydrochloride and naltrexone hydrochloride)

Further information

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