Mumbai, Sept. 5 -- Synthon has filed an abbreviated new drug application (ANDA) with the US Food and Drug Administration (FDA) seeking approval for Ozanimod capsules, indicated for the treatment of relapsing forms of multiple sclerosis.

The company has already received tentative FDA approval within 30 months of filing, positioning the product for a shared 180-day exclusivity period upon launch.

Under the agreement, Synthon will be responsible for securing final regulatory approval, as well as the manufacturing and supply of the product. Zydus will take charge of commercialisation in the US market.

Zeposia (Ozanimod) is a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis, inc...