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Twyneo FDA Approval History

Last updated by Judith Stewart, BPharm on July 26, 2021.

FDA Approved: Yes (First approved July 26, 2021)
Brand name: Twyneo
Generic name: tretinoin and benzoyl peroxide
Dosage form: Cream
Company: Sol-Gel Technologies, Ltd.
Treatment for: Acne

Twyneo (tretinoin and benzoyl peroxide) is a topical retinoid and antibacterial fixed-dose combination for the treatment of acne vulgaris in adults and children 9 years of age and older.

  • Tretinoin and benzoyl peroxide are widely prescribed separately as a combination treatment for acne, but benzoyl peroxide causes degradation of tretinoin and potentially reduces its effectiveness if used at the same time or combined in the same formulation. Twyneo utilizes microencapsulation technology to separate the two active ingredients thereby maintaining the effectiveness of tretinoin.
  • Twyneo is applied in a thin layer to the affected areas once daily.
  • Twyneo can cause serious adverse reactions including hypersensitivity reactions and photosensitivity. Common adverse reactions include pain, dryness, exfoliation, erythema, dermatitis, pruritus and irritation (all at the application site).

Development timeline for Twyneo

Jul 27, 2021Approval FDA Approves Twyneo (tretinoin and benzoyl peroxide) for the Treatment of Acne Vulgaris
Dec  7, 2020Sol-Gel Technologies Announces FDA Acceptance for Filing of New Drug Application for Twyneo for the Treatment of Acne Vulgaris

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.