Endo International plc (OTC: ENDPQ), an American-Irish specialty pharmaceutical company, announced on Thursday that its Par Sterile Products business has commenced shipping Posaconazole injection (18mg/mL), the first generic version of Merck's Noxafil, in the United States.
This move follows the US Food and Drug Administration's (FDA) final approval of the drug's Abbreviated New Drug Application.
The product is indicated for prophylaxis of invasive Aspergillus and Candida infections in subjects who are at high risk of developing these infections because of 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.
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Endo International launches first generic version of Merck's Noxafil