Drugs firm Strides Pharma Science on Monday said its subsidiary has received approval from the US health regulator to market Amantadine Hydrochloride Softgel Capsules, used to treat infection caused by various strains of influenza A virus, in the American market.
The company’s step-down wholly-owned subsidiary, Strides Pharma Global Pte Ltd Singapore, has received approval from the US Food and Drug Administration (USFDA) for the medication, the company said in a statement. The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Symmetrel Capsules, 100 mg, of Endo Pharmaceuticals, Inc (Endo). According to IQVIA MAT December 2021 data, the US market for Amantadine Hydrochloride Capsules USP,100 mg, is around USD 11 million.
The product will be manufactured at the company’s facility in Bengaluru and will be marketed by Strides Pharma Inc in the US market, the drug firm stated. Strides Pharma Science also has approval for Amantadine Hydrochloride tablets, and the combined market size of tablets and capsules together is around USD 21 million.
