FDAsafety guidance66% confidence
FDA AP — OXYCODONE AND ACETAMINOPHEN (SUPPL)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Amgen; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application ANDA040105. Sponsor: PH HEALTH. Submission status: AP. Submission type: SUPPL. Active ingredients: ACETAMINOPHEN, OXYCODONE HYDROCHLORIDE.
Supporting Context
- Therapeutic area
- Bone Health · Osteoporosis
- Sub-indication
- General
Related signal: FDA Submission Update for Prolia (Denosumab) by Amgen