FDAsafety guidance66% confidence
FDA AP — ARGATROBAN IN SODIUM CHLORIDE (SUPPL)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Cipla; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application NDA022434. Sponsor: CIPLA. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: ARGATROBAN.
Supporting Context
- Therapeutic area
- Neurology · Migraine
- Sub-indication
- General
Related signal: Cipla's ANDA214209 for Sumatriptan Receives Abbreviated Approval from FDA