Unichem Labs gets USFDA nod to market its spasticity relief tablets

The company has received abbreviated new drug application (ANDA) approval to market its Baclofen tablets USP 10 mg, 20 mg from the United States Food and Drug Administration (USFDA), Unichem Laboratories said in a BSE filing.

New Delhi, July 10 (PTI) Drug firm Unichem Laboratories on Friday said it has received approval from the US health regulator to market its Baclofen tablets indicated for alleviation of spasticity resulting from multiple sclerosis. The company has received  abbreviated new drug application (ANDA) approval to market its Baclofen tablets USP 10 mg, 20 mg from the United States Food and Drug Administration (USFDA), Unichem Laboratories said in a BSE filing. The product is a generic version of Novartis Pharmaceuticals Corp's Lioresal tablets in the same strengths, it added.

The tablets will be commercialised from the company's Ghaziabad plant, Unichem Laboratories said. Baclofen tablets are indicated for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity, it added.

Shares of Unichem Laboratories were trading at Rs 188.25 per scrip on the BSE, up 2.09 per cent over previous close..