Alembic Pharma gets tentative USFDA approval for Treprostinil injection

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.