NDAOPHTHALMIC, OTICOINTMENT
Lifecycle
Pre-Launch
Clinical Trials
1
Data completeness
3/8 — Basic
HYDROCORTONE (hydrocortisone acetate) by Merck & Co. is clinical pharmacology cortifoam provides effective topical administration of an anti-inflammatory corticosteroid as adjunctive therapy of ulcerative proctitis. Approved for atopic dermatitis.
Drug data last refreshed 2w ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
HYDROCORTONE (hydrocortisone acetate) is a topical corticosteroid ointment administered via ophthalmic and otic routes for anti-inflammatory indications including atopic dermatitis. It works by suppressing local inflammatory responses and immune activity at the site of application. The product is currently in pre-launch stage under NDA sponsorship by Merck & Co.
Pre-Launch
Pre-launch positioning creates opportunity for launch-focused roles; Merck team size and resources will depend on competitive intensity assessment.
Mechanism of Action
CLINICAL PHARMACOLOGY Cortifoam provides effective topical administration of an anti-inflammatory corticosteroid as adjunctive therapy of ulcerative proctitis. Direct observations of methylene blue-containing foam have shown staining about 10 centimeters into the rectum.
Clinical Trials (1)
Pharmacokinetics and Bioavailability of Hydrocortisone Acetate Suppositories
Started Mar 2016
16 enrolled
Healthy
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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.