Wynzora 64 mg/g
Calcipotriene and Betamethasone dipropionate · CREAM · MC2 Therapeutics Ltd
Wynzora is a cream containing calcipotriene and betamethasone dipropionate at 64 mg/g, taken topical. Manufactured by MC2 Therapeutics Ltd.
Key Facts
- Brand Name
- Wynzora
- Generic Name
- Calcipotriene and Betamethasone dipropionate
- NDC Code (Product)
73499-001- Manufacturer
- MC2 Therapeutics Ltd
- Strength
- 64 mg/g
- Dosage Form
- CREAM
- Route
- TOPICAL
- Marketing Status
- Application #
- NDA213422
- Drug Class
- Vitamin D Analog [EPC]
- Marketing Start
- 06/30/2021
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 WYNZORA Cream is indicated for the topical treatment of plaque psoriasis in patients 18 years of age and older. WYNZORA Cream is a combination of calcipotriene, a vitamin D analog, and betamethasone dipropionate, a corticosteroid, indicated for the topical treatment of plaque psoriasis in patients 18 years of age and older. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Apply WYNZORA Cream to affected areas once daily for up to 8 weeks. Rub in gently to ensure that the plaques are saturated with the cream. Do not use more than 100 g per week. Discontinue therapy when control is achieved. Do not use: with occlusive dressings unless directed by a healthcare provider on the face, groin, or axillae, or if skin atrophy is present at the treatment site WYNZORA Cream is not for oral, ophthalmic, or intravaginal use. Apply WYNZORA Cream to affected areas once daily for up to 8 weeks. ( 2 ) Discontinue therapy when control is achieved. ( 2 ) Do not use more than 100 g per week. ( 2 ) Do not use with occlusive dressings unless directed by a physician. ( 2 ) Avoid use on the face, groin, or axillae, or if skin atrophy is present at the treatment site. ( 2 ) Not for oral, ophthalmic, or intravaginal use. ( 2 )
Contraindications
4 CONTRAINDICATIONS None. None ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS The most common adverse reactions reported by more than 1% of subjects treated with WYNZORA Cream were upper respiratory infection, headache, and application site irritation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact MC2 Therapeutics Ltd at 1-800-644-8240 or FDA at 1-800-FDA-1088 or 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. The rates of adverse reactions given below were reported in a randomized, multicenter, prospective, vehicle and active controlled clinical trial in adult subjects with plaque psoriasis. Subjects applied WYNZORA Cream, calcipotriene/betamethasone dipropionate topical suspension, 0.005%/0.064% or vehicle once daily for 8 weeks. The mean weekly dose of WYNZORA Cream was 33.8 g. A total of 342 subjects were treated with WYNZORA Cream, 337 with calcipotriene/betamethasone dipropionate topical suspension, 0.005%/0.064% and 115 with vehicle. The majority of subjects…
Frequently Asked Questions
What is Wynzora used for?
Wynzora contains Calcipotriene and Betamethasone dipropionate. It is a cream taken topical. Consult your doctor for specific uses.
Is Wynzora a controlled substance?
Wynzora is not classified as a controlled substance by the DEA.
What is the generic name for Wynzora?
The generic name for Wynzora is Calcipotriene and Betamethasone dipropionate. There are 5 other brand versions of Calcipotriene and Betamethasone dipropionate.
What is the NDC code for Wynzora 64 mg/g?
The NDC (National Drug Code) for Wynzora 64 mg/g is 73499-001, listed by MC2 Therapeutics Ltd.