Posaconazole injection is indicated for prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised

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Posaconazole injection is indicated for the treatment of invasive aspergillosis in adults and pediatric patients 13 years of age and older. (Credit: Diana Polekhina on Unsplash)

Endo International plc (OTC: ENDPQ) announced today that its Par Sterile Products business has begun shipping posaconazole injection (18 mg/mL), the first generic version of Merck’s Noxafil in the U.S., following final approval from the U.S. Food and Drug Administration of its Abbreviated New Drug Application.

“We’re pleased to provide choices to healthcare providers,” said Scott Sims, Senior Vice President and General Manager, Injectable Solutions & Generics at Endo. “The first generic version of Noxafil injection does just that, while also strengthening our product portfolio and underscoring our reputation as a reliable, quality supplier.”

Posaconazole injection is indicated for 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 (low white blood cell counts) from chemotherapy.

According to IQVIA, Noxafil vial sales were approximately $25 million for the 12 months ended May 31, 2023.

Source: Company Press Release