Alembic Pharma secures USFDA nod for Treprostinil Injection to treat pulmonary arterial hypertension

Vadodara: Alembic Pharmaceuticals Limited today 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 (1 O 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 (10mg/ml), of United Therapeutics Corp. (United).

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 US$ 466.1 million for twelve months ending Dec. 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.