Drug firm Zydus Cadila on Friday said it has received final approval from the US health regulator to market Fingolimod capsules and Verapamil Hydrochloride Injection.
Fingolimod capsules are indicated for the treatment of patients with relapsing forms of multiple sclerosis. While, Verapamil Hydrochloride Injection, is used to rapidly/temporarily restore normal heartbeats in people with certain heart rhythm disorders.
Zydus Cadila has received final approval from the United States Food and Drug Administration (USFDA) to market Fingolimod capsules, (Gilenya) in the strengths of 0.5 mg, Zydus Cadila, part of Cadila Healthcare group, said in a regulatory filing.
The company said 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 (Isoptin Injection),” Zydus Cadila said.
The injections will be manufactured at the company’s manufacturing facility at Jarod, near Vadodara.
The group now has 305 approvals and has so far filed over 390 abbreviated new drug applications since the commencement of the filing process in 2003-04.
Shares of Cadila Healthcare were trading 2.85 percent higher at Rs 427.45 apiece on BSE.