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USFDA approval to Zydus to market Teriflunomide tablets for MS relapse


USFDA approval to Zydus to market Teriflunomide tablets for MS relapse

Zydus group now has 237 approvals from the USFDA and has so far filed over 340 abbreviated new drug applications.

New Delhi: Drug firm Zydus Cadila recently said that it has received an approval from the US health regulator to market Teriflunomide tablets, used to treat relapsing forms of multiple sclerosis (MS). The company has received an approval from the United States Food and Drug Administration (USFDA) to market Teriflunomide Tablets – 7 mg and 14 mg – in the US market, Zydus Cadila said in a statement.

“It will be manufactured at the group’s formulations manufacturing facility at special economic zone (SEZ), Ahmedabad,” it added.

Teriflunomide is not a cure for MS but is thought to work by decreasing certain immune system cells (lymphocytes) which can attack the nerves in the brain and spinal cord.
“This helps decrease the number of flare-ups (relapses) and may help slow down physical problems caused by MS,” it added.
Zydus group now has 237 approvals from the USFDA and has so far filed over 340 abbreviated new drug applications (ANDAs) since the commencement of the filing process in FY 2003-04.



Source: PTI
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