Drug firm Zydus Cadila on Thursday said it has received tentative approval from the US health regulator to market Fingolimod capsules, used in the treatment of multiple sclerosis, in the American market.
The company has received tentative approval from the US Food and Drug Administration (USFDA) to market the product in the strength of .25 mg, Zydus Cadila said in a statement.
Earlier, in October 2020, the Ahmedabad-based group had received approval to market the Fingolimod capsules in the strength of .5mg.
Fingolimod is an immunomodulating drug. It is a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis (MS).
The drug will be manufactured at the Zydus's manufacturing facility at the SEZ, Ahmedabad.
The group now has 319 approvals and has so far filed over 400 abbreviated new drug applications (ANDAs) since the commencement of the filing process in 2003-04.