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Wynzora FDA Approval History

FDA Approved: Yes (First approved July 20, 2020)
Brand name: Wynzora
Generic name: calcipotriene and betamethasone dipropionate
Dosage form: Cream
Company: MC2 Therapeutics
Treatment for: Plaque Psoriasis

Wynzora (calcipotriene and betamethasone dipropionate) is a PAD™ Cream formulation of the vitamin D analog calcipotriene, and the corticosteroid betamethasone dipropionate, indicated for the topical treatment of plaque psoriasis in patients 18 years of age and older.

  • Wynzora Cream uses PAD™ Technology, which enables stability of both calcipotriene and betamethasone dipropionate in a convenient-to-use aqueous formulation. PAD™ Vehicles are oil-in-water dispersions that use less surfactant compared to conventional formulations, thereby enabling high tolerability on sensitive skin.
  • Wynzora Cream is applied to affected areas once daily for up to 8 weeks.
  • Common adverse reactions include upper respiratory infection, headache, and application site irritation.

Development Timeline for Wynzora

DateArticle
Jul 22, 2020Approval FDA Approves Wynzora Cream (calcipotriene and betamethasone dipropionate) for Adults with Plaque Psoriasis
Nov 20, 2019MC2 Therapeutics Announces FDA Acceptance of its New Drug Application for Wynzora™ Cream for Treatment of Plaque Psoriasis
Sep 24, 2019MC2 Therapeutics Announces Submission of NDA for Wynzora Cream (Calcipotriene 0.005% and Betamethasone Dipropionate 0.064%) for Treatment of Plaque Psoriasis

Further information

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