Zydus Cadila gets US FDA approval for fingolimod capsules and verapamil hydrochloride injection

Zydus Cadila has received final approval from the USFDA to market Fingolimod Capsules, 0.5 mg (US RLD: Gilenya Capsules).

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 group’s formulation manufacturing facility at the SEZ, Ahmedabad.

The Company has also received the final approval from the USFDA to market Verapamil Hydrochloride Injection USP, 5 mg/2 mL (2.5 mg/mL) and 10 mg/4 mL (2.5 mg/mL), Single-Dose Vials (US RLD: Isoptin Injection). The injections will be manufactured at the company’s manufacturing facility at Jarod, near Vadodara (formerly known as Liva Pharmaceuticals). Verapamil injection is used to rapidly or temporarily restore normal heartbeats in people with certain heart rhythm disorders.

The group now has 305 approvals and has so far filed over 390 ANDAs since the commencement of the filing process in FY 2003-04.