Winlevi 1 g/100g
Clascoterone · CREAM · Sun Pharmaceutical Industries, Inc.
Winlevi is a cream containing clascoterone at 1 g/100g, taken topical. Manufactured by Sun Pharmaceutical Industries, Inc..
Key Facts
- Brand Name
- Winlevi
- Generic Name
- Clascoterone
- NDC Code (Product)
47335-994- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Strength
- 1 g/100g
- Dosage Form
- CREAM
- Route
- TOPICAL
- Marketing Status
- Application #
- NDA213433
- Drug Class
- Androgen Receptor Inhibitor [EPC]
- Marketing Start
- 10/04/2021
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE WINLEVI (clascoterone) cream is an androgen receptor inhibitor indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. WINLEVI (clascoterone) cream is an androgen receptor inhibitor indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Cleanse the affected area gently. After the skin is dry, apply a thin uniform layer of WINLEVI cream twice per day, in the morning and the evening, to the affected area. Avoid accidental transfer of WINLEVI cream into eyes, mouth or other mucous membranes. If contact with mucous membranes occurs, rinse thoroughly with water. WINLEVI cream is for topical use only. WINLEVI cream is not for ophthalmic, oral or vaginal use. Apply a thin layer (approximately 1 gram) to affected area twice daily (morning and evening). Avoid contact with eyes, mouth, and mucous membranes. ( 2 ) Not for ophthalmic, oral or vaginal use. ( 2 )
Contraindications
4 CONTRAINDICATIONS None. None ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS Most common adverse reactions occurring in 7 to 12% of patients are erythema/reddening, pruritus and scaling/dryness. Additionally, edema, stinging, and burning occurred in >3% of patients and were reported in a similar percentage of subjects treated with vehicle. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. 1-800-818-4555 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In two identical multicenter, randomized, double-blind, vehicle-controlled trials, 1421 subjects 12 years and older with facial acne vulgaris applied WINLEVI cream or vehicle twice daily for 12 weeks. Overall, 62% of the subjects were female, and 38% were male, 91% of the patients were Caucasian, and the mean age was 19.7 years. Local skin reactions (edema, erythema/redness, pruritus, scaling/dryness, skin atrophy, stinging/burning, striae rubrea, telan…
Frequently Asked Questions
What is Winlevi used for?
Winlevi contains Clascoterone. It is a cream taken topical. Consult your doctor for specific uses.
Is Winlevi a controlled substance?
Winlevi is not classified as a controlled substance by the DEA.
What is the generic name for Winlevi?
The generic name for Winlevi is Clascoterone. There are no other listed brand versions of Clascoterone.
What is the NDC code for Winlevi 1 g/100g?
The NDC (National Drug Code) for Winlevi 1 g/100g is 47335-994, listed by Sun Pharmaceutical Industries, Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)