Caplin Steriles Limited (CSL), a subsidiary of Caplin Point Laboratories Limited, has received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Foscarnet Sodium Injection (6000 mg/250 mL Infusion Bag).

The approved product is a generic therapeutic equivalent of Foscavir Injection from Clinigen Healthcare Ltd..

Foscarnet Sodium Injection is an antiviral therapy used to treat cytomegalovirus (CMV) retinitis in AIDS patients and herpes simplex virus (HSV) infections in immunocompromised individuals.

According to IQVIA data, the approved dosage strength of Foscarnet Sodium Injection recorded US sales of approximately $15 million for the 12-month period ending March 2026.

The approval further strengthens Caplin Steriles’ growing portfolio of complex injectable products in the US market and reinforces the company’s focus on expanding its presence in regulated markets through niche and hospital-focused generic formulations.