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# FDA Approves Teva’s Opioid Dependence Drug
- URL: https://www.fdaweb.com/fda-approves-tevas-opioid-dependence-drug/
- Published: 2018-09-10T12:00:00.000Z
- Updated: 2026-09-15T00:30:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142308

FDA has approved a Teva 505(b)(2) NDA for Cassipa (buprenorphine and naloxone) sublingual film for the maintenance treatment of opioid dependence. The approval provides a new dosage strength (16mg/4mg) of buprenorphine and naloxone sublingual film, which is also approved in both brand name and generic versions and in various strengths. “Medication-assisted treatment (MAT) is a comprehensive approach that combines FDA-approved medications (currently methadone, buprenorphine, or naltrexone) with counseling and other behavioral therapies to treat patients with opioid use disorder (OUD),” an [agency release](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm619864.htm?ref=fdaweb.com) says. “Regular adherence to MAT with buprenorphine reduces opioid withdrawal symptoms and the desire to use opioids, without causing the cycle of highs and lows associated with opioid misuse or abuse.”