Alembic Pharmaceuticals receives USFDA Tentative nod for Treprostinil Injection by admin- Monday, September 7th, 2020 04:30:06 PM
Alembic Pharmaceuticals has introduced that its fully owned subsidiary Alembic Global Holdings SA has received tentative approval from the United States 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.Five mg/ml), one hundred mg/20 ml (5 mg/ml), and 2 hundred mg/20 ml (1 O mg/ml), Multiple-Dose Vials. The tentatively accepted 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), a hundred mg/20 ml (five mg/ml), and 2 hundred mg/20 ml (10mg/ml), of United Therapeutics Corp. (United). Treprostinil Injection is indicated for the remedy of pulmonary arterial high blood pressure (PAH; WHO Group 1) to decrease symptoms associated with exercising.
Treprostinil Injection has an expected market size of US$ 466.1 million for 12 months ending Dec. 2019 in keeping with United Therapeutics Corporation’s 2019 economic results.
Alembic now has a complete of 131 ANDA approvals from USFDA.