FDA Approves Market Generic Version Of Paxil

Armen Hareyan's picture

FDA has granted final approval for Caraco Pharmaceutical's Abbreviated New Drug Application for paroxetine hydrochloride tablets, USP (Paroxetine HCl).


Paroxetine HCl is a psychotropic drug, which is indicated for the treatment of major depressive disorder, panic disorder, obsessive compulsive disorder, social anxiety disorder, generalized anxiety disorder, and posttraumatic stress disorder. Our generic paroxetine is the bioequivalent to Paxil(R), a registered trademark of GlaxoSmithKline. According to IMS Data, for the twelve months ended March 2007, paroxetine HCl generic and brand products (Paxil(R)) had annual sales of approximately $330 million. Caraco has four strengths available, 10mg, 20mg, 30mg and 40mg tablets.

Daniel H. Movens, Caraco's Chief Executive Officer, said, "We are pleased to gain this approval as it complements our portfolio and fortifies our product offering by expanding our product line. We plan to market this product to the generic pharmaceutical market immediately. This will bring our total product selection to 34 different products represented by 70 various strengths."

Detroit-based Caraco Pharmaceutical Laboratories, Ltd., develops, manufactures, markets and distributes generic and private-label pharmaceuticals to the nation's largest wholesalers, distributors, drugstore chains and managed care providers.

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