Alembic Pharmaceuticals receives USFDA Tentative Approval for Treprostinil Injection

  • Posted on: 8 September 2020
  • By: PharmaTutor News

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Alembic Pharmaceuticals Limited 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 (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.

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