Lupin receives FDA approval for Generic Paxil CR tablets

The tablets are used to treat major depressive disorder, panic disorder, social anxiety disorder and premenstrual dysphoric disorder

Lupin has received final approval for its Paroxetin extended release tablets USP, 12.5 mg, 25 mg and 37.5 mg from the United States Food and Drug Administration (FDA) to market a generic version of Apotex Technologies’ Paxil CR tablets, 12.5 mg, 25 mg and 37.5 mg. Lupin shall commence promoting the product shortly.

Lupin’s Paroxetin extended release tablets USP, 12.5 mg, 25 mg and 37.5 mg are the AB rated generic equivalents of Apotex Technologies’ Paxil CR tablets, 12.5 mg, 25 mg and 37.5 mg. It is indicated for the treatment of major depressive disorder, panic disorder, social anxiety disorder and premenstrual dysphoric disorder.

Paxil CR tablets had US sales of $127.7 million.