Skip to Content

Buprenorphine Approval Status

FDA Approved: No
Generic name: buprenorphine
Dosage form: Sublingual Spray
Company: Insys 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 Status and FDA Approval Process for buprenorphine

DateArticle
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

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide