Caplin Steriles receives USFDA approval for Foscarnet Sodium Injection

Caplin Steriles (CSL), a subsidiary company of Caplin Point Laboratories has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Foscarnet Sodium Injection (6000 mg/250 mL Infusion Bag), a generic therapeutic equivalent version of the Reference Listed Drug (RLD) Foscavir Injection from Clinigen Healthcare, (NDA 020068).

Foscarnet Sodium Injection is an antiviral medication used to treat CMV retinitis in AIDS patients and HSV infection in immunocompromised individuals. According to IQVIATM (IMS Health), Foscarnet Sodium Injection, (6000 mg/250 mL Infusion Bag) had US sales of approximately $15 million for the 12-month period ending March 2026.