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Belbuca Approval History

  • FDA approved: Yes (First approved October 23rd, 2015)
  • Brand name: Belbuca
  • Generic name: buprenorphine hydrochloride
  • Dosage form: Buccal Film
  • Company: Endo Pharmaceuticals Inc.
  • Treatment for: Chronic Pain

Belbuca (buprenorphine) is a partial opioid agonist analgesic in a buccal film formulation for the management of chronic pain.

Development History and FDA Approval Process for Belbuca

Oct 26, 2015Approval FDA Approves Belbuca (buprenorphine) Buccal Film for Chronic Pain Management
Feb 23, 2015Endo Pharmaceuticals and BioDelivery Sciences Announce Acceptance of NDA for Belbuca (buprenorphine HCl) Buccal Film for Chronic Pain
Jul  7, 2014Endo and Biodelivery Sciences Announce Positive Top-Line Results From The Phase III Clinical Trial Of BEMA Buprenorphine
Jan 27, 2014Endo and BioDelivery Sciences Announce Positive Top-Line Results from the Phase III Clinical Trial of BEMA Buprenorphine in Opioid Naïve Patients with Chronic Pain
Sep 28, 2011BioDelivery Sciences Announces Results from Phase 3 Efficacy Study for BEMA Buprenorphine in Chronic Pain
Dec 17, 2009BioDelivery Sciences Announces Positive Phase 2 Pain Trial Results for BEMA Buprenorphine
Mar 18, 2009BEMA Buprenorphine to Proceed to Phase 2 Following Favorable Initial Study Results

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