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.
Par Health launches generic version of Janumet XR tablets in US
EQL Pharma gains approval to sell Mellozzan in Kazakhstan
Newbury Pharmaceuticals receives Swedish approval for generic tofacitinib
Breckenridge launches Tofacitinib Tablets, generic equivalent to Pfizer's Xeljanz
Hims & Hers expands GLP-1 offering in Canada with generic semaglutide
Apotex announces commercial launch of Apo-Semaglutide Injection in Canada
Transpire Bio's generic high-strength Trelegy Ellipta ANDA accepted for filing by US FDA
Kaiser Permanente reports study findings showing significant cost savings
Apotex receives Health Canada approval for a generic Ozempic equivalent
Cipla's AB-rated Ventolin HFA generic receives US FDA approval
Newbury Pharmaceuticals secures first Scandinavian approval for palbociclib generic
Apotex's generic Ozempic (Semaglutide Injection) receives US FDA tentative approval
DifGen and Apotex report FDA approval of generic Nintedanib Soft Gel Capsules