Gland Pharma has received approval from the United States Food and Drug Administration (US FDA) for generic Foscarnet Sodium Injection, 6000 mg/250 mL (24 mg/mL) Single-Dose Bag for Infusion. Generic Foscarnet Sodium Injection is the bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Foscavir Injection, 24 mg/mL, of Clinigen Healthcare. With this approval, Gland Pharma secured the first generic offering status in Single-Dose Bag for Infusion.
Foscarnet Sodium Injection is indicated for the treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS). It is also used for the treatment of acyclovir-resistant mucocutaneous herpes simplex virus (HSV) infections in immunocompromised patients. The Foscarnet Sodium Injection, 6000 mg/250 mL (24 mg/mL) and its generic equivalents had US sales of around $28 million for twelve months ending in January 2021, according to IQVIA.
Gland Pharma develops, manufactures and markets complex injectables. The company sells its products primarily under a business-to-business model in over 60 countries, including the US, Canada, Australia and India.
