Prevents disseminated Mycobacterium avium complex (MAC) disease. ANDA 212430, held by Pharmazone. Rifabutin.
As of Nov 15, 2026, ANDA 212430 (Rifabutin), held by Pharmazone, was first approved by FDA on Mar 19, 2026, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Rifabutin capsules are indicated for the prevention of disseminated Mycobacterium avium complex (MAC) disease in patients with advanced HIV infection.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 19, 2026 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Rifabutin150MG · capsule;oral | Rifabutin | Rx |
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
