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# FDA Approves Teva’s Cassipa for Opioid Dependence
- URL: https://www.fdaweb.com/fda-approves-tevas-cassipa-for-opioid-dependence/
- Published: 2018-09-07T12:00:00.000Z
- Updated: 2026-09-15T00:30:25.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142300

FDA has approved Teva’s Cassipa (buprenorphine and naloxone) sublingual film for maintenance treatment of opioid dependence. An agency [statement](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm619864.htm?ref=fdaweb.com) says the approval provides a new 16 mg/4 mg dosage strength of buprenorphine and naloxone sublingual film. The drug was approved through the 505(b)(2) abbreviated approval pathway that relied, in part, on an FDA finding of safety and effectiveness for Suboxone sublingual film to support approval.

The statement says that Teva demonstrated that reliance on the FDA finding of safety and effectiveness for Suboxone was scientifically justified and provided Cassipa-specific pharmacokinetic data to establish the drug’s safety and efficacy for its approved uses.

Cassipa should be used as part of a complete treatment plan that includes counseling and psychosocial support, FDA says, and should only be used after patient induction and stabilization up to a dose of 16 mg of buprenorphine using another marketed product.

Adverse events commonly associated with the buprenorphine and naloxone sublingual film are oral hypoesthesia, glossodynia, oral mucosal erythema, headache, nausea, vomiting, hyperhidrosis, constipation, signs and symptoms of withdrawal, insomnia, pain, and peripheral edema. The products may only be prescribed by Drug Addiction Treatment Act-certified prescribers.