NDATOPICALCREAM
Approved
Sep 1997
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
Drug data last refreshed 15h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NORITATE is a topical 1% metronidazole cream approved in 1997 for rosacea and other dermatologic and systemic infections. Metronidazole is a nitroimidazole antimicrobial whose mechanism of action in rosacea remains unknown, though it demonstrates broad activity against anaerobic bacteria and parasites. Topical application results in minimal systemic absorption (<1% of oral dosing).
$3MPart D
LOE ApproachingDeclining
Minimal commercial activity with only 1,454 Part D claims in 2023; limited team expansion likely given approaching loss of exclusivity.
Mechanism of Action
Pharmacologic Class:
Nitroimidazole Antimicrobial
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Chlorhexidine and/or Metronidazole Plus FB301 Pre-treatment Trial
Started Mar 2026
120 enrolled
Bacterial Vaginosis (BV)
A Single-center, Open-label, Study Evaluating Safety and Pharmacokinetics of Single Doses of Zidebactam-Cefepime and Metronidazole Alone or in Combination.
Started Jan 2025
30 enrolled
PHA1A
Effectivity and Safety of Metronidazole 1% Cream in Rosacea Therapy
Started May 2023
48 enrolled
Rosacea
Personalized AZithromycin/metronidAZole Therapy in Pediatric Crohn's Disease (CD)
Started Aug 2021
13 enrolled
Crohn DiseasePediatric Crohns Disease
Ceftolozane/Tazobactam (MK-7625A) Plus Metronidazole Versus Meropenem for Participants With Complicated Intra-abdominal Infection (MK-7625A-015)
Started Mar 2019
268 enrolled
Complicated Intra-abdominal Infections
Worked on NORITATE at Bausch + Lomb? Share your interview experience or compensation data (+7 days Pro)
Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.