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Zydus Cadila gets USFDA nod for generic muscle spasm treatment tablets

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.

November 27, 2018 / 14:53 IST
Aurobindo Pharma Ltd.

Drug firm Zydus Cadila on 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.

PTI
first published: Nov 27, 2018 02:49 pm

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