FDAapproval84% confidence
FDA Approves First Generic of Priftin (rifapentine) Tablets
Source: FDA
Why This Matters
Why this matters: sets a approval precedent in the same sub-indication (ild) as Chattem Sanofi; the same agency is already in play for this signal, so precedent weight is higher.
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
- Allergy · Antihistamine
- Sub-indication
- Ild
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