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FDA approval · 2018-02-01

FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma)

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Summary

FDA approved a supplemental ANDA for a generic buprenorphine and naloxone product manufactured by PAI Holdings, expanding access to this opioid use disorder tre…

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Diseases / indications

Drugs mentioned

  • Buprenorphine and naloxone (BUPRENORPHINE AND NALOXONE)

Snippet

SUPPL AP for BUPRENORPHINE AND NALOXONE (BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE)