FDAsafety guidance66% confidence
FDA AP — OXYCODONE AND ASPIRIN (SUPPL)
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (pain) as Sun Pharma; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application ANDA040255. Sponsor: ANI PHARMS. Submission status: AP. Submission type: SUPPL. Active ingredients: ASPIRIN, OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE.
Supporting Context
- Therapeutic area
- Pain Management · Opioid Combination
- Sub-indication
- Pain
Related signal: FDA Approval Letter for Oxycodone and Aspirin Combination