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Buprenorphine FDA Approval Status

FDA Approved: No
Generic name: buprenorphine
Dosage form: Sublingual Spray
Company: Benuvia Therapeutics Inc.
Treatment for: Pain

Buprenorphine Sublingual Spray is a novel sublingual spray formulation of the partial mu-opioid agonist buprenorphine in development for the management of moderate-to-severe acute pain.

Development timeline for buprenorphine

DateArticle
Jun 26, 2024New publication shows effectiveness data for weekly and monthly buprenorphine injections in treating opioid dependence in individuals using fentanyl
Jul 27, 2018INSYS Therapeutics Receives Complete Response Letter from FDA for Buprenorphine NDA
May 22, 2018INSYS Therapeutics Confirms Outcome of FDA Advisory Committee Meeting on Buprenorphine Sublingual Spray
Dec  6, 2017FDA Accepts New Drug Application (NDA) for Buprenorphine Sublingual Spray from INSYS Therapeutics
Sep 29, 2017INSYS Therapeutics Files New Drug Application (NDA) for Buprenorphine Sublingual Spray with FDA

Further information

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