Treats only CCR5-tropic human immunodeficiency virus type 1 (HIV-1) infection. ANDA 216143, held by Rhodes Pharms. Maraviroc.
As of Nov 15, 2026, ANDA 216143 (Maraviroc), held by Rhodes Pharms, was first approved by FDA on Nov 4, 2025, with 0 approved supplements and 0 published complete response letters.
Maraviroc tablets are indicated in combination with other antiretroviral agents for the treatment of only CCR5-tropic human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients 2 years of age and older weighing at least 10 kg. Limitations of Use: Maraviroc tablets are not recommended in patients with dual/mixed- or CXCR4-tropic HIV-1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 4, 2025 | 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
