The FDA has approved Clinigen Healthcare's supplemental new drug application (sNDA) for Foscavir (foscarnet sodium), a treatment for HIV/AIDS-related cytomegalovirus (CMV) infections and herpes.
Hospira will distribute Foscavir to US patients on an emergency supply basis in September 2011.
Clinigen Group chief executive Peter George said, "We've already established good penetration across Europe, but because we didn't initially have a US license, the country's contribution to overall Foscavir sales has been relatively modest."
Clinigen has also entered into an agreement with BL&H to market and distribute Foscavir locally.
Clinigen and BL&H are working to seek Korean marketing authorizations for Foscavir, both in its primary indications and as a treatment for CMV in hematopoietic stem cell transplant (HSCT) patients (bone marrow transplants).
