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