Zydus Cadila gets USFDA nod for Baclofen, a muscle spasm treatment tablet

Zydus Cadila has received final approval from the USFDA to market Baclofen tablets in the strengths of 10 mg and 20 mg

Drug firm Zydus Cadila Tuesday said it has received final nod from the US health regulator to market generic Baclofen tablets used for treatment of muscle spasms.

The company has received final approval from the United States Food and Drug Administration (USFDA) to market Baclofen tablets in the strengths of 10 mg and 20 mg, Zydus Cadila said in a filing to BSE.

The tablets will be manufactured at the group's formulations manufacturing facility at Baddi, it added.

"Baclofen is used to treat muscle spasms caused by certain conditions such as multiple sclerosis, spinal cord injury/disease. It works by helping to relax the muscles," Zydus Cadila said.
 

The group now has 234 approvals and has so far filed over 340 abbreviated new drug applications (ANDAs) since the commencement of its filing process, it added.
 

Shares of Cadila Healthcare, the listed entity of the group were trading at Rs 345.10 per scrip on BSE, down 2.31 per cent from its previous close.