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Alembic Pharmaceuticals announced that its wholly-owned subsidiary
Alembic Global Holding SA has received final 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 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 (United).
Treprostinil Injection is indicated for the treatment of pulmonary arterial
hypertension (PAH;WHO Group 1) to diminish symptoms associated with
exercise. In patients with PAH requiring transition from epoprostenol, Treprostinil
Injection is indicated to diminish the rate of clinical deterioration. Alembic had
previously received tentative approval for this ANDA.
Treprostinil Injection has an estimated market size of US$ 17 million for twelve
months ending December 2020 according to IQVIA.
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