It was reported on Monday that the US Food and Drug Administration (USFDA) has granted approval to Teva Pharmaceuticals USA, a subsidiary of Teva Pharmaceutical Industries Limited, for its Cassipa sublingual film as a maintenance treatment for opioid dependence.
USFDA has approved new dosage strength (16mg / 4mg) of Cassipa (buprenorphine and naloxone) sublingual film. It is also approved in both brand name and generic versions and various strengths, in combination with counselling and other behavioural therapies to treat patients with opioid use disorder (OUD).
According to USFDA, the product must be used under a complete treatment plan, with up to a dose of 16mg of buprenorphine using another marketed product.
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