Alembic gets USFDA final nod for Treprostinil injection

Treprostinil Injection is indicated for the treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to diminish symptoms associated with exercise.

82
Medicine Injection
Picture: Pixabay

Last Updated on February 14, 2021 by The Health Master

Alembic Pharma 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 (1mg/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.

FDA

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Remodulin Injection, 20 mg/20 mL (1mg/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.

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 $17 million for twelve months ending December 2020 according to IQVIA.

Alembic now has a total of 138 ANDA approvals (121 final approvals and 17 tentative approvals) from USFDA, including this first injectable ANDA approval.


Also read:

Glenmark gets USFDA nod for generic Clindamycin phosphate gel

Lupin gets US FDA nod to market generic Tavaborole topical solution

Alembic Pharma gets 5 observations from USFDA


The Health Master is now on Telegram. For latest update on health and Pharmaceuticals, subscribe to The Health Master on Telegram.

Follow and connect with us on Facebook and Linkedin

Go to main website, click here

Subscribe for daily free updates, click here

For daily free updates on WhatsApp, click here

Subscribe here for daily updates
Loading