BioCentury
ARTICLE | Clinical News

Bunavail regulatory update

June 16, 2014 7:00 AM UTC

BioDelivery said FDA approved an NDA for Bunavail buprenorphine naloxone as maintenance treatment for opioid dependence. The application was submitted under section 505(b)(2) of the Food, Drug and Cosmetic Act, which allows sponsors to reference data on safety and efficacy from the scientific literature or from previously approved products. The company said it plans to launch the product late next quarter, but has not yet finalized the price.

BioDelivery plans to partner the product in regions outside of the U.S. ...