FDAsafety guidance66% confidence
FDA AP — LEVORPHANOL TARTRATE (SUPPL)
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (copd) as AstraZeneca; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application ANDA211484. Sponsor: ACERTIS PHARMS. Submission status: AP. Submission type: SUPPL. Active ingredients: LEVORPHANOL TARTRATE.
Supporting Context
- Therapeutic area
- Respiratory · Asthma/COPD
- Sub-indication
- COPD
Related signal: FDA Accepts Supplemental Application for SYMBICORT AEROSPHERE