Remoxy Approval Status
- FDA approved: No
- Brand name: Remoxy
- Generic name: oxycodone
- Company: Pain Therapeutics, Inc.
- Treatment for: Pain
Remoxy ER (oxycodone) is a long-acting abuse-resistant narcotic analgesic formulation in development for the treatment of moderate to severe chronic pain.On September 26, 2016, Pain Therapeutics, Inc. announced the receipt of a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) on the resubmission of its new drug application (NDA) for Remoxy ER (oxycodone capsules CII). The CRL identified further actions and studies required to obtain approval of Remoxy ER with label claims on three routes of abuse (injection, inhalation and snorting).
Development Status and FDA Approval Process for Remoxy
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