Treats human immunodeficiency virus (HIV-1) infection. ANDA 204024, held by Sun Pharm. Fosamprenavir Calcium.
As of Nov 15, 2026, ANDA 204024 (Fosamprenavir Calcium), held by Sun Pharm, was first approved by FDA on Nov 20, 2019, with 1 approved supplement and 0 published complete response letters.
Fosamprenavir calcium tablets are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection. The following points should be considered when initiating therapy with fosamprenavir calcium tablets plus ritonavir in protease inhibitor-experienced patients: The protease inhibitor-experienced patient trial was not large enough to reach a definitive conclusion that fosamprenavir calcium tablets plus ritonavir and lopinavir plus ritonavir are clinically equivalent. Once-daily administration of fosamprenavir calcium tablets plus ritonavir is not recommended for adult protease inhibitor-experienced patients or any pediatric patients.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 20, 2019 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Fosamprenavir CalciumEQ 700MG BASE · tablet;oral | Fosamprenavir Calcium | Rx |
| Apr 22, 2025 | Supplement 9Labeling · Standard review | Approved | None posted |
| Nov 20, 2019 | Original application | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
