Rifabutin

Prevents disseminated Mycobacterium avium complex (MAC) disease. ANDA 215041, held by Novitium Pharma. Rifabutin.

As of Nov 15, 2026, ANDA 215041 (Rifabutin), held by Novitium Pharma, was first approved by FDA on Dec 17, 2021, with 1 approved supplement and 0 published complete response letters.

First approved: Dec 17, 2021
Review: Standard
Supplements approved: 1
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS & USAGE Rifabutin capsules are indicated for the prevention of disseminated Mycobacterium avium complex (MAC) disease in patients with advanced HIV infection.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Dec 17, 2021	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Rifabutin150MG · capsule;oral	Rifabutin	Rx

All 2 submissions, including labeling and manufacturing supplements


Jul 10, 2025	Supplement 15Labeling · Standard review	Approved	None posted
Dec 17, 2021	Original application	Approved	None posted

Identifiers

Application: ANDA 215041
Drugs@FDA: Overview at FDA
Company: Novitium Pharma

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