FDA — authorised 29 January 2002
- Application: ANDA075600
- Marketing authorisation holder: PADAGIS US
- Local brand name: PODOFILOX
- Indication: SOLUTION — TOPICAL
- Status: approved
🇺🇸 PODOFILOX in United States
FDA authorised PODOFILOX on 29 January 2002 · 66 US adverse-event reports
Marketing authorisations
FDA — authorised 21 July 2010
- Application: ANDA090184
- Marketing authorisation holder: BAUSCH AND LOMB INC
- Local brand name: PODOFILOX
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 22 November 2023
- Application: ANDA211871
- Marketing authorisation holder: PADAGIS US
- Local brand name: PODOFILOX
- Indication: GEL — TOPICAL
- Status: approved
FDA
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 66
Most-reported reactions
- Pain — 9 reports (13.64%)
- Application Site Pain — 8 reports (12.12%)
- Drug Ineffective — 8 reports (12.12%)
- Drug Interaction — 8 reports (12.12%)
- Hypersensitivity — 7 reports (10.61%)
- Tremor — 7 reports (10.61%)
- Anxiety — 5 reports (7.58%)
- Off Label Use — 5 reports (7.58%)
- Pruritus — 5 reports (7.58%)
- Asthenia — 4 reports (6.06%)
PODOFILOX in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Infectious Disease approved in United States
Frequently asked questions
Is PODOFILOX approved in United States?
Yes. FDA authorised it on 29 January 2002; FDA authorised it on 21 July 2010; FDA authorised it on 22 November 2023.
Who is the marketing authorisation holder for PODOFILOX in United States?
PADAGIS US holds the US marketing authorisation.