FDAsafety guidance77% confidence
FDA AP — LEUPROLIDE ACETATE (SUPPL)
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (prostate cancer) as Sun Pharma; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application ANDA075471. Sponsor: MEITHEAL. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: LEUPROLIDE ACETATE.
Supporting Context
- Therapeutic area
- Oncology · Hormonal Therapy
- Sub-indication
- Prostate Cancer
Related signal: FDA Grants AP Status for Leuprolide Acetate ANDA078885 by Sun Pharma