FDAsafety guidance66% confidence
FDA AP — COPAXONE (SUPPL)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Teva; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application NDA020622. Sponsor: TEVA PHARMS USA. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: GLATIRAMER ACETATE.
Supporting Context
- Therapeutic area
- Women's Health · Contraceptive
- Sub-indication
- General
Related signal: Teva's ANDA219324 for Junel FE Receives Approval Status from FDA