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Cassipa FDA Approval History

Last updated by Judith Stewart, BPharm on March 2, 2021.

FDA Approved: Yes (Discontinued) (First approved September 7, 2018)
Brand name: Cassipa
Generic name: buprenorphine and naloxone
Dosage form: Sublingual Film
Company: Teva Pharmaceuticals USA, Inc.
Treatment for: Opiate Dependence - Maintenance

Marketing Status: Discontinued

Cassipa (buprenorphine and naloxone) sublingual film is a partial‐opioid agonist and opioid antagonist combination indicated for the maintenance treatment of opioid dependence.

Cassipa is the first buprenorphine and naloxone sublingual film product to be approved in the new higher dosage strength (buprenorphine 16 mg / naloxone 4 mg). Suboxone sublingual film and its generic equivalents are available in lower strengths: 2 mg/0.5mg, 4 mg/1 mg, 8 mg/2mg and 12mg/3mg.

Development timeline for Cassipa

Sep  7, 2018Approval FDA Approves Cassipa (buprenorphine and naloxone) Sublingual Film as Maintenance Treatment for Opioid Dependence

Further information

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