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Apadaz Approval Status

  • FDA approved: No
  • Brand name: Apadaz
  • Generic name: acetaminophen and benzhydrocodone hydrochloride
  • Previous name: KP201
  • Company: KemPharm, Inc.
  • Treatment for: Pain

Apadaz (acetaminophen and benzhydrocodone hydrochloride) is an investigational abuse-deterrent narcotic analgesic combination in development for the short-term management of acute pain.

On June 13, 2016, KemPharm, Inc. announced the receipt of a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for Apadaz. A CRL indicates that the application is not ready for approval in its present form.

Development Status and FDA Approval Process for Apadaz

Jun 13, 2016FDA Issues Complete Response Letter for Apadaz New Drug Application
May  5, 2016Statement Regarding FDA Advisory Committee Meeting on KemPharm’s Abuse-Deterrent Product Candidate Apadaz
Apr 16, 2013KemPharm Advances KP201 Clinical and Commercial Program with Completion of Tablet Registration Activities
May 24, 2011KemPharm, Inc. Announces Positive Results from Phase 1 Trial of KP201 for Pain

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