Zydus Cadila Ltd. said it has received the final nod from the U.S. health regulator to market Baclofen tablets, used to treat muscle spasms caused by certain conditions, in the America.
The company has received final approval from the United States Food and Drug Administration (U.S. FDA) to market Baclofen tablets in the strength of 5 mg, according to a company 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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