Cipla Gets US Regulator's Nod For Generic Antidepressant

New Delhi: Drug firm Cipla on Tuesday said its US arm InvaGen Pharmaceuticals Inc has received a final approval from the US Food and Drug Administration (FDA) to market generic Bupropion Hydrochloride extended release tablets used for treatment of major depressive disorder.

"InvaGen Pharmaceuticals Inc has received final approval for its abbreviated new drug application (ANDA) for Bupropion Hydrochloride extended release tablets (XL), 150 mg and 300 mg, from the United States Food and Drug Administration (American health regulator)," Cipla said in a statement.

The product is available for shipping immediately, it added.

The company's tablets are generic versions of Valeant's Wellbutrin XL tablets in the same strengths, Cipla said.

"The tablets are indicated for the treatment of major depressive disorder (MDD) and prevention of seasonal affective disorder (SAD)," it added.

Wellbutrin XL tablets and generic equivalents had US sales of approximately $792 million for the 12 month period ending June 2016, according to IMS Health, Cipla said.

At 2:33 p.m., shares in Cipla were trading 0.76 per cent higher at Rs 571.50 apiece on the BSE, whose benchmark Sensex was up 1.32 per cent.