Treats CMV retinitis. ANDA 202501, held by Avet Lifesciences. Cidofovir.
As of Nov 15, 2026, ANDA 202501 (Cidofovir), held by Avet Lifesciences, was first approved by FDA on Jul 26, 2012, with 1 approved supplement and 0 published complete response letters.
INDICATION AND USAGE Cidofovir injection is indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS). THE SAFETY AND EFFICACY OF CIDOFOVIR INJECTION HAVE NOT BEEN ESTABLISHED FOR TREATMENT OF OTHER CMV INFECTIONS (SUCH AS PNEUMONITIS OR GASTROENTERITIS), CONGENITAL OR NEONATAL CMV DISEASE, OR CMV DISEASE IN NON-HIV-INFECTED INDIVIDUALS. DESCRIPTION OF CLINICAL TRIALS Three phase II/III controlled trials of cidofovir injection have been conducted in HIV-infected patients with CMV retinitis.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 26, 2012 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| CidofovirEQ 375MG BASE/5ML (EQ 75MG BASE/ML) · solution;intravenous | Cidofovir | Rx |
| Jan 17, 2013 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jul 26, 2012 | 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
