FDA tentatively OKs new dosage strength of Zydus’ generic Gilenya
Zydus Cadilla had previously received the agency's approval to market the generic in a 0.5 mg dosage strength.
Zydus Cadila has received tentative approval from the Food and Drug Administration to market fingolimod capsules in a 0.25 mg dosage strength.
The product is the generic of Gilenya capsules. Earlier, in October 2020, the group was granted approval to market fingolimod capsules in the a dosage strength of 0.5 mg.
Fingolimod is an immunomodulating drug. It is a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of multiple sclerosi.
The drug will be manufactured at the group’s formulation manufacturing facility at the SEZ, Ahmedabad.