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Aximris XR FDA Approval Status

Last updated by Judith Stewart, BPharm on Jan 30, 2020.

FDA Approved: No
Brand name: Aximris XR
Generic name: oxycodone hydrochloride
Dosage form: Extended-Release Tablets
Previous Name: Rexista
Company: Intellipharmaceutics International Inc.
Treatment for: Pain

Aximris XR (oxycodone hydrochloride extended release) is an abuse and alcohol-deterrent controlled-release formulation of oxycodone hydrochloride in development for the relief of moderate to severe pain.

Development Timeline for Aximris XR

DateArticle
Jan 16, 2020Intellipharmaceutics Provides Update on FDA Advisory Committees Meeting for Aximris XR (Oxycodone Hydrochloride extended release) an Abuse Deterrent Opioid Analgesic for the Treatment of Moderate to Severe Pain
Mar  4, 2019Intellipharmaceutics Announces Resubmission of New Drug Application to the U.S. FDA for its Oxycodone ER
Sep 25, 2017Intellipharmaceutics Receives Complete Response Letter from the FDA for Rexista NDA
Feb  2, 2017Intellipharmaceutics Announces FDA Acceptance for Filing of NDA for Rexista (oxycodone hydrochloride extended release) Abuse Deterrent Opioid Analgesic
Nov 25, 2016Intellipharmaceutics Submits NDA for Rexista (oxycodone hydrochloride extended release), an Abuse Deterrent Opioid Analgesic for the Treatment of Moderate to Severe Pain

Further information

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