Alembic Global Holding SA receives USFDA Final Approval for Treprostinil Injection
Posted On: 2021-02-12 22:33:27 (Time Zone: Arizona, USA)
Alembic Pharmaceuticals Limited has 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, Trepros
Search jobs 13-Jan-2021 Treprostinil Drugs Industry Share Analysis | Market Size to Worth over Billions | Latest Trends and Growth Strategies by Coherent Market Insights
Treprostinil is a synthetic prostacyclin prescribed for the treatment of pulmonary arterial hypertension. Treprostinil works as a vasodilator lowering the blood pressure in the pulmonary artery leading from heart to lungs and is known to improve the ability to exercise. Treprostinil can be administered through oral route (orenitram), through inhaler (Tyvaso), and through infusion (Remodulin).
Global Treprostinil Drugs Market – Dynamics
A significant value is being generated every year by the companies that are involved in manufacturing and selling of treprostinil. For instance, in September 2018, United Therapeutics Corporation announced its financial results for the year 2018, where it stated that that global sales for Treprostinil were valued at around US$ 599 m