FDAapproval83% confidence
FDA Approves First Generic of Priftin (rifapentine) Tablets
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable approval decision relevant to Roche.
Regulatory Analysis
Food and Drug Administration has approved the first generic of Priftin (rifapentine) tablets, a medication for the treatment of active pulmonary tuberculosis (TB) caused by Mycobacterium tuberculosis in combination with one or more antituberculosis drugs.
Supporting Context
- Therapeutic area
- Infectious Diseases · Tuberculosis
- Sub-indication
- General
Related signal: Roche's Elecsys IGRA TB Test Receives CE Mark for Tuberculosis Detection