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Aurobindo Receives FDA Approval for Posaconazole Delayed-Release Tablets, 100 mg

Published: July 18, 2024

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Posaconazole Delayed-Release Tablets, 100 mg. Aurobindo Pharma’s Posaconazole Delayed-Release Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), Noxafil Delayed-Release Tablets manufactured by Merck, Sharp & Dohme LLC.

Posaconazole Delayed-Release Tablets are indicated for:

  • The Prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy.