Skip to main content

SequestOx FDA Approval Status

FDA Approved: No
Brand name: SequestOx
Generic name: naltrexone and oxycodone hydrochloride
Company: Elite Pharmaceuticals, Inc.
Treatment for: Pain

SequestOx (oxycodone hydrochloride and naltrexone) is an abuse-deterrent opioid formulation in development for the management of moderate to severe pain.

In July 2016, Elite Pharmaceuticals, Inc. announced the receipt of a Complete Response Letter (CRL) from the U.S. Food and Drug Administration regarding the New Drug Application (NDA) for SequestOx. The CRL determined that the NDA was not ready for approval in its present form.

Development timeline for SequestOx

Dec 22, 2016Elite Provides Update On SequestOx New Drug Application
Jul 15, 2016FDA Issues Complete Response Letter For SequestOx New Drug Application
Mar 17, 2016Elite Announces U.S. FDA Priority Review Designation for SequestOx NDA

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.