Unichem Labs gets US FDA approval to market anxiety-disorder tablets

Drug firm Unichem Laboratories on Friday said it has received approval from the US health regulator to market its generic Buspirone Hydrochloride tablets used for management of anxiety disorders.

The company has received abbreviated new drug application (ANDA) approval from the United States Food and Drug Administration (USFDA) to market its Buspirone Hydrochloride tablets USP, in the strengths of 5 mg, 10 mg, 15 mg, and 30 mg, Unichem Laboratories said in a BSE filing.

The company's tablets are a generic version of Bristol-Myers Squibb Company's Buspar tablets in the same strengths, it added.

The product will be commercialised from the company's Ghaziabad plant, Unichem said.

Buspirone Hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety, it added.

Shares of Unichem Laboratories closed at Rs 149.85 per scrip on BSE, up 5.16 per cent from its previous close.