Mumbai : Pharma firm Strides Shasun Limited announced that its subsidiary Strides Pharma Global Pte Limited, Singapore has received tentative approval from the United States Food & Drug Administration (USFDA) for its Para IV filing of Fingolimod capsules.
“We have received tentative approval from the USFDA for its Para IV filing of Fingolimod Capsules, 0.5 mg. Fingolimod capsules is used for treatment of adult patients with relapsing forms of multiple sclerosis. The product is currently sold by Novartis under the brand name GILENYA,” a company statement said here.
“The product on generic market formation is expected to be launched in February 2019, with a potential 180 day exclusivity,” said the statement.
On receiving full approval, the product will be manufactured at the company’s oral dosage facility at Bangalore and marketed by its subsidiary in USA, Strides Pharma Inc, it added.