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Aurobindo receives FDA nod for posaconazole delayed-release tablets

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 100mg.

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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 100mg. Aurobindo Pharma’s posaconazole delayed-release tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), Noxafil DR Tablets, manufactured by of Merck, Sharp & Dohme.

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.

Posaconazole delayed-release tablets has an estimated market size of US $68 Million for the twelve months ending May 2024, as per IQVIA.

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