Gland Pharma 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. Gland Pharma is backward integrated with in-house API source for this product. Gland Pharma intends to supply this product globally and recently launched the product in the Canadian market. Global markets size is estimated to be $50 million.