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New Delhi: Drug firm Zydus Cadila on Saturday said it has received final nod from the US health regulator to market Baclofen tablets, used for treatment of muscle spasms caused by some conditions, in the American market. The company has received final approval from the United States Food and Drug Administration (USFDA) to market Baclofen tablets in the strength of 5 mg, Zydus Cadila said in a statement.
The product 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 and spinal cord injury/disease. It works by helping to relax the muscles, Zydus Cadila said.
The group now has 288 approvals and has so far filed over 386 abbreviated new drug applications (ANDAs) since the commencement of its filing process.
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