Caplin Steriles Secures USFDA Approval for Antiviral Foscarnet Sodium Injection
Caplin Steriles receives USFDA approval for Foscarnet Sodium Injection
Business Standard
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Caplin Steriles, a subsidiary of Caplin Point Laboratories, has received final approval from the United States Food and Drug Administration (USFDA) for its generic Foscarnet Sodium Injection, used to treat viral infections in immunocompromised patients. The drug, which had US sales of around $15 million for the year ending March 2026, is a therapeutic equivalent to Clinigen Healthcare's Foscavir Injection.
- 01Foscarnet Sodium Injection is indicated for treating CMV retinitis in AIDS patients and HSV infections in immunocompromised individuals.
- 02The approved formulation is a 6000 mg/250 mL infusion bag.
- 03The reference drug, Foscavir Injection, is marketed by Clinigen Healthcare.
- 04US sales for Foscarnet Sodium Injection were approximately $15 million for the year ending March 2026.
- 05The approval was granted under the Abbreviated New Drug Application (ANDA) process.
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Caplin Steriles (CSL), a subsidiary of Caplin Point Laboratories, has received final approval from the United States Food and Drug Administration (USFDA) for its Foscarnet Sodium Injection, a generic version of the antiviral medication Foscavir Injection from Clinigen Healthcare. This medication is used to treat cytomegalovirus (CMV) retinitis in patients with AIDS and herpes simplex virus (HSV) infections in immunocompromised individuals. The approved formulation is presented in a 6000 mg/250 mL infusion bag. According to IQVIATM (IMS Health), the Foscarnet Sodium Injection had US sales of approximately $15 million for the 12-month period ending March 2026, indicating a significant market opportunity for Caplin Steriles.
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