FDA approves Orexo’s low-dose Zubsolv

SILVER SPRING, Md. — The Food and Drug Administration has approved Orexo’s Zubsolv (buprenorphine 0.7 mg/naloxone 0.18 mg) sublingual tablets, the company announced Thursday. The drug is indicated to treat patients with opioid dependence. 

 

With this approval, Orexo now has FDA approval for six dosage strength tablets: 11.4 mg buprenorphine/2.9 mg naloxone, 8.6 mg/2.1 mg, 5.7 mg/1.5 mg, 2.9 mg/0.71 mg, 1.4 mg/0.36 mg and 0.7 mg/0.18 mg. 

 

“The FDA approval of the 0.7mg/0.18mg dose constitutes yet another important milestone for the opioid-dependent community and Orexo,” Orexo US president Robert DeLuca said. “ZUBSOLV extends its widest range of dosage strengths offered which further enables single tablet once daily dosing including the lowest dosage strength available.”