USFDA14 May 2026, 07:01 pm
Caplin Steriles Gets USFDA Nod for Foscarnet Sodium Injection
AI Summary
Caplin Point Laboratories' subsidiary, Caplin Steriles Limited, received final approval from the USFDA for its ANDA Foscarnet Sodium Injection (6000 mg/250 mL Infusion Bag), a generic version of Foscavir Injection from Clinigen Healthcare Ltd. The drug, an antiviral medication, is used to treat CMV retinitis in AIDS patients and HSV infection in immunocompromised individuals. US sales for Foscarnet Sodium Injection were approximately $15 million for the 12 months ending March 2026, according to IQVIA (IMS Health).
Key Highlights
- Caplin Steriles received USFDA approval for Foscarnet Sodium Injection.
- The drug is a generic therapeutic equivalent to Foscavir Injection.
- Foscarnet Sodium Injection treats CMV retinitis and HSV infection.
- US sales for the injection reached $15 million in the last 12 months.