Alembic Pharma gets tentative USFDA approval for Treprostinil injection
It is indicated for the treatment of pulmonary arterial hypertension to diminish symptoms associated with exercise
Alembic Pharma announced that its wholly-owned subsidiary Alembic Global Holdings SA has received tentative approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Treprostinil injection, 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.
The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Remodulin Injection, 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 (1 Omg/ml), of United Therapeutics Corp.
Treprostinil injection is indicated for the treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to diminish symptoms associated with exercise.
Treprostinil injection has an estimated market size of $ 466.1 million for twelve months ending December 2019 according to United Therapeutics Corporation’s 2019 financial results.
Alembic now has a total of 131 ANDA approvals (113 final approvals and 18 tentative approvals) from USFDA.