Last Updated : Monday, June 22, 2020 18:32:53

ALEMBIC PHARMA gets USFDA nod to sell medicine to treat risk of stroke

VADODARA (BARODA) / MUMBAI / RAJKOT – In a regulatory filing as submitted to the Indian Stock Exchanges, Vadodara (Baroda) headquartered Alembic Pharmaceuticals Ltd said of having got USFDA (US Food & Drugs Administration) nod to sell medicine to treat risk of stroke and allied illness.

In a press-release titled, “Alembic Pharmaceuticals receives USFDA Tentative Approval for Rivaroxaban Tablets, 10 mg, 15 mg, and 20 mg”, as attached and enclosed with the regulatory filing as submitted by the company to the Indian Bourses, it further read that, Alembic Pharmaceuticals Limited today announced that the Company has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Rivaroxaban Tablets, 10 mg, 15 mg, and 20 mg.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Xarelto Tablets, 10 mg, 15 mg, and 20 mg, of Janssen Pharmaceuticals, Inc. (Janssen).

Rivaroxaban Tablets are indicated for

  • i) the reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.
  • ii) the treatment of deep vein thrombosis (DVT).
  • iii) the treatment of pulmonary embolism (PE).
  • iv) the reduction in the risk of recurrence of deep vein thrombosis and of pulmonary embolism following initial 6 months treatment for DVT and/or PE. 
  • v) the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery.

Rivaroxaban Tablets, 10 mg, 15 mg, and 20 mg have an estimated market size of US$ 6.1 billion for twelve months ending March 2020 according to IQVIA.

Alembic now has a total of 124 ANDA approvals (110 final approvals and 14 tentative approvals) from USFDA.

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