The tentatively approved product is therapeutically equivalent to the reference listed drug product Remodulin injection of United Therapeutics Corp.
Alembic Global Holdings SA has received tentative approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Treprostinil Injection in the strengths of 20 mg/20 ml (1 mg/ml), 50 mg/20 ml (2.5 mg/ml), 100 mg/20 ml (5 mg/ml), and 200 mg/20 ml (10 mg/ml), multiple-dose vials, Alembic Pharmaceuticals said in a regulatory filing.
Quoting United Therapeutics Corporation’s 2019 financial results, Alembic Pharma said Treprostinil injection has an estimated market size of USD 466.1 million for the 12 months ending December 2019.
Alembic now has a total of 131 ANDA approvals (113 final approvals and 18 tentative approvals) from the USFDA.
Shares of Alembic Pharmaceuticals were trading 1.55 per cent lower at Rs 913 apiece on the BSE.