BRIEF—FDA approves new maintenance therapy for opioid dependence

Shares of Teva Pharmaceutical Industries were down 1.1% at $21.50 by close of New York trading on Friday, after the US Food and Drug Administration announced that it had approved the Israeli generics giant’s Cassipa (buprenorphine and naloxone) sublingual film for the maintenance treatment of opioid dependence.

This action provides a new dosage strength (16mg/4mg) of buprenorphine and naloxone sublingual film, which is also approved in both brand name and generic versions and in various strengths.

Cassipa was approved through an abbreviated approval pathway under the Federal Food, Drug, and Cosmetic Act.

A new drug application submitted through this pathway may rely on the FDA’s finding that a previously approved drug is safe and effective or on published literature to support the safety and/or effectiveness of the proposed product, if such reliance is scientifically justified.

In the case of Cassipa, the manufacturer submitted a 505(b)(2) application that relied, in part, on the FDA’s finding of safety and effectiveness for Indivior’s Suboxone sublingual film to support approval.