Alembic Pharma secures USFDA nod for Treprostinil Injection to treat pulmonary arterial hypertension
Treprostinil Injection is indicated for the treatment of pulmonary arterial hypertension(PAH; WHO group 1) to dimnish symptoms associated with exercise;
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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).
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