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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
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.
Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world.
Read also: Alembic Pharma JV gets USFDA nod to Desonide Lotion
Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751