Wynzora

Wynzora is an FDA-registered drug product whose active ingredient is CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE. It is labelled by MC2 Therapeutics Ltd taken by topical and marketed as a human prescription drug product. Identifiers on file: NDC 73499-001, application NDA213422, label effective 20231129. It is one of 4 FDA drug label records sharing the active ingredient CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE are most often described in connection with: wynzora cream, topical treatment, plaque psoriasis, patients years, combination calcipotriene, vitamin analog, betamethasone dipropionate, corticosteroid indicated. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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 )

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 )

4 CONTRAINDICATIONS None. None ( 4 )

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 were White (87%) and male (62%). Approximately 72% were non-Hispanic/Latino. The mean age was 52 years and ages ranged from 18 to 89 years. The most common adverse reactions reported by ≥1% of subjects treated with WYNZORA Cream and more frequently than vehicle are presented in Table 1 below. Table 1: Adverse Reactions Through Week 8 Preferred Term WYNZORA Cream (N=342) Vehicle Cream (N=115) Upper Respiratory Infection (URI) Includes nasopharyngitis, upper respiratory tract infection (URTI), and viral URTI 7% 5% Headache 2% 0% Application site irritation 1% 0% 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of topical corticosteroids. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Postmarketing reports for local adverse reactions to topical corticosteroids included: atrophy, striae, telangiectasias, itching, dryness, hypopigmentation, perioral dermatitis, secondary infection, and miliaria. Ophthalmic adverse reactions of cataracts, glaucoma, and increased intraocular pressure, have been reported during use of topical corticosteroids, including topical betamethasone products.

FDA lists 4 drug label records with CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is Wynzora used for?
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 )

Who makes Wynzora?
MC2 Therapeutics Ltd is the labeler of record for Wynzora. 4 FDA label records share the active ingredient CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Wynzora come in?
administered by topical. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Wynzora prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE?
Yes. 4 FDA drug label records list CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Wynzora been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.