Drug firm Cipla said its US arm InvaGen Pharmaceuticals Inc has received final approval from the American health regulator 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,” 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 USD 792 million for the 12 month period ending June 2016, according to IMS Health, Cipla said.
Shares of Cipla were today trading at Rs 570.25 per scrip in the afternoon trade on BSE, up 0.54 per cent from its previous close.