FDA approves the medium tablet strength, 2.9 mg/0.71 mg, of ZUBSOLV®
Uppsala, Sweden – June 10, 2015 – Orexo AB (publ) announces today that it has received approval from the U.S. Food and Drug Administration (FDA) of medium dosage strength of ZUBSOLV® (buprenorphine/naloxone CIII sublingual tablet) for maintenance treatment of opioid dependence. The new dosage strength is 2.9 mg/0.71 mg buprenorphine/naloxone CIII sublingual tablets. The new 2.9 mg/0.71 mg dosage strength is expected to be launched during second half of 2015. The new dosage strength complements the existing strengths of 1.4 mg/0.36 mg, 5.7 mg/1.4 mg, 8.6 mg/2.1 mg and 11.4 mg/2.9 mg