Mylan Launches Generic Subutex Sublingual Tablets - Quick Facts

(RTTNews) - Mylan N.V. (NASDAQ: MYL) and Mylan Inc. announced the U.S. launch of Buprenorphine Hydrochloride Sublingual Tablets, 2 mg and 8 mg, which is the generic version of Reckitt Benckiser's Subutex Sublingual Tablets.

Mylan said it received final approval from the U.S. Food and Drug Administration or FDA for its Abbreviated New Drug Application or ANDA for this product, which is indicated for the treatment of opioid dependence and is preferred for induction.

Buprenorphine Hydrochloride Sublingual Tablets, 2 mg and 8 mg had U.S. sales of about $107.8 million for the 12 months ending December 31, 2014, according to IMS Health.