FDAsafety guidance66% confidence
FDA AP — CIPROFLOXACIN HYDROCHLORIDE (SUPPL)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Alembic Pharmaceuticals; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application ANDA076558. Sponsor: HIKMA. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: CIPROFLOXACIN HYDROCHLORIDE.
Supporting Context
- Therapeutic area
- Neurology · Multiple Sclerosis
- Sub-indication
- General
Related signal: FDA Approves Fingolimod Hydrochloride Application by Alembic