FDAsafety guidance83% confidence
FDA AP — ENZALUTAMIDE (ORIG)
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (prostate cancer) as Merck Sharp & Dohme LLC.
Regulatory Analysis
Application ANDA216068. Sponsor: SANDOZ. Submission status: AP. Submission type: ORIG. Review priority: STANDARD. Active ingredients: ENZALUTAMIDE.
Supporting Context
- Therapeutic area
- Oncology · Prostate Cancer
- Sub-indication
- Prostate Cancer
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