FDA approves Osmotica's generic Effexor

WASHINGTON The Food and Drug Administration has given final approval to Osmotica Pharmaceutical for a treatment for major depressive disorder and social anxiety disorder.

Osmotica received approval for 37.5 mg, 75 mg, 150 mg and 225 mg extended-release tablets of the drug venlafaxine hydrochloride. The drug is bioequivalent to Wyeth’s Effexor XR when administered under fed conditions. Osmotica will launch the product line for the two FDA-approved indications soon.

Osmotica is part of the multinational Osmotica Group, a group of companies with primary operations in the U.S. and Argentina that specializes in neurological drugs and technologies.