Caraco Pharmaceutical Announces FDA Approval to Market Generic Paxil

July 3, 2007

Caraco Pharmaceutical Laboratories announced that the FDA granted final approval for the company’s abbreviated new drug application for Paroxetine HCl tablets, a generic form of GlaxoSmithKline’s Paxil.

Paroxetine HCl (paroxetine hydrochloride) is a psychotropic drug, indicated for the treatment of major depressive disorder, panic disorder, obsessive-compulsive disorder, social anxiety disorder, generalized anxiety disorder and posttraumatic stress disorder, Caraco said.

The company said that, according to IMS Data for the 12 months ending in March, paroxetine HCl generic and Paxil had annual sales of approximately $330 million.

Caraco said the drug now comes in four strengths, 10-, 20-, 30- and 40-mg tablets.