Zydus Cadila receives tentative approval from USFDA for Fingolimod Capsules .25mg

Zydus Cadila has received tentative approval from the United States US (FDA) to market Fingolimod capsules in the strength of .25 mg (US RLD: Gilenya capsules), the company informed in a statement.

It also said that earlier, in October 2020, the group was granted approval to market Fingolimod capsules in the strength of .5mg. It is one of immunomodulating medical and surgical supplies. 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 group’s formulation manufacturing facility at the SEZ, Ahmedabad,” added the statement.

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 FY 2003-04, it said.