Regulations

FDA Approves Differin Epiduo Acne Gel As New OTC Acne Treatment

OTC version of the Galderma treatment is labeled for adults and children 12 years and older.

Photo: Galderma

The US Food & Drug Administration (FDA) has approved Differin Epiduo Acne Gel as new over the counter (OTC) acne treatment. It was previously available only by prescription.

The Galderma-developed treatment combines two active ingredients, adapalene and benzoyl peroxide, in a once-daily gel for adults and teens 12 years and older. It will continue to be available by prescription for children 9 through 11 years of age, according to FDA.

Differin’s OTC History

Galderma received approval from FDA or Differin Gel (adapalene gel 0.1%) as OTC treatment for acne in 2016, as reported by Happi. That approval made Differin Gel the first OTC acne product containing a full prescription-strength retinoid. It was also the first FDA-approved active ingredient to be introduced to the OTC acne category in more than three decades.

OTC Market

The OTC marketplace offers consumers treatments and remedies for acne and more. You can read more about this market in this feature from Happi.

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