FDAsafety guidance77% confidence
FDA AP — PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE (SUPPL)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Dr. Reddy's Labs; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application ANDA208175. Sponsor: DR REDDYS LABS SA. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: PHENTERMINE HYDROCHLORIDE, TOPIRAMATE.
Supporting Context
- Therapeutic area
- Urology · 5-Alpha Reductase Inhibitor
- Sub-indication
- General
Related signal: FDA Grants AP Status for Finasteride ANDA076437 by Dr. Reddy's Labs