FDAsafety guidance77% confidence
FDA AP — MYCOPHENOLATE SODIUM (SUPPL)
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (nmus rehab) as Mankind Pharma; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application ANDA091558. Sponsor: APOTEX INC. Submission status: AP. Submission type: SUPPL. Active ingredients: MYCOPHENOLATE SODIUM.
Supporting Context
- Therapeutic area
- Anesthesia · Neuromuscular Blockade
- Sub-indication
- Nmus Rehab
Related signal: FDA Accepts Sugammadex Sodium Application from Mankind Pharma