Endo International has revealed that its Par Sterile Products division is now shipping posaconazole injection (18 mg/mL) in the United States. This marks the first generic version of Merck’s Noxafil, following the final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application.

Posaconazole injection is prescribed for the prevention of invasive Aspergillus and Candida infections. These serious infections can pose significant risks to patients who are severely immunocompromised. Key patients include hematopoietic stem cell transplant (HSCT) recipients suffering from graft-versus-host disease (GVHD) or those with hematologic malignancies who are experiencing prolonged neutropenia (low white blood cell counts) resulting from chemotherapy.

As per IQVIA data, Noxafil vial sales in the US were estimated at approximately $25 million for the 12 months ended May 31, 2023. This milestone from Endo International and its Par Sterile Products business is expected to provide a more cost-effective alternative for treating patients at high risk of these invasive fungal infections.

  Endo International, Merck, NOXAFIL, Posaconazole, US FDA, US Food and Drug Administration, USA