Differin Extends With Cleanser, Moisturizer, Bioré Adds Foam In OTC Skin Care
This article was originally published in The Rose Sheet
Executive Summary
Galderma Labs receives FDA approval for new labeling for its OTC Differin acne treatment and launches cleanser and moisturizer under the brand. Kao USA extends its Bioré line with acne cleansing foam and Naturopathix updates packaging for its ZymaDerm homeopathic indicated for molluscum skin infections.
Galderma Laboratories L.P. looks to boost sales for its Differin OTC skin care brand anchored by an acne treatment gel with the introduction of a cleanser and a moisturizer.
The division of Nestle SA subsidiary Galderma SA, a year after launching Differin Gel following FDA approval of an Rx-to-OTC switch of the active ingredient 0.1% adapalene gel, also has FDA approval for a label change for the once-daily acne treatment.
Elsewhere in the OTC skin care market, Kao USA Inc. extends its product line with Bioré Baking Soda Acne Cleansing Foam and Naturopathix Inc. rolls out new packaging for its ZymaDerm homeopathic indicated for molluscum contagiosum skin infections and expands distribution to CVS pharmacies.
In a Feb. 21 announcement, Galderma Labs said that after it "made a splash" into the OTC acne treatment market with Differin Gel, it's offering Differin Deep Cleanser and Differin Oil Control Moisturizer.
The cleanser offers the efficacy of maximum-strength benzoyl peroxide but causes less irritation and redness while the moisturizer with SPF 30 is an oil-free, lightweight moisturizer, the firm said. The cleanser costs $10.44 and the moisturizer $11.99, both in 4-ounce containers, on Amazon.com
FDA on March 23 approved Galderma Labs' supplemental NDA for 0.1% adapalene for changes to the product labeling, which had been changed in May 2017 from the labeling included with the product's OTC switch approval. In addition to altering the design and colors used for the brand name and the text "0.1% Adapalene Gel Acne Treatment," Galderma Labs removed from the package-front panel the statements "First FDA-Approved Over-The-Counter Topical Retinoid For Acne Treatment" and "Dermatologist Developd And Tested."
The newly approved labels also "Once Daily Topical Retinoid" and "FDA approved" and move "Previously available only by prescription" to the top of the package-front statements.
Fort Worth, Texas-based firm Galderma Labs introduced Differin Gel, approved as a once-daily OTC topical for treating acne in consumers 12 and up, in early 2017 after receiving FDA approval for an NDA for a partial switch of 0.1% adapalene gel in 2016. PS118
The product was the first new acne ingredient to become available OTC in 20 years and the first nonprescription acne treatment approved through a new drug application. Differin OTC was approved with a three-year market exclusivity allowed for OTC switches proposed in NDAs that, at FDA's request, include clinical trials.
Galderma Labs and other firms continue to market Rx 0.1% adapalene products in creams and lotions.
Bioré Foam, ZymaDerm Distribution
New York-based Kao on March 27 said its Bioré line extension formulated for combination skin contains OTC acne monograph ingredient salicylic acid like other Bioré products but adds a baking soda-containing foam to deep-clean skin. The foam formula rinses easily after cleansing gently and effectively while controlling and minimizing stubborn acne and blemishes.
Kao markets the foam product at a suggested retail produce of $6.49 at drug, grocery and mass merchandise retail chains. The Bioré line also includes Baking Soda Acne Scrub and Charcoal Acne Scrub or Clearing Cleanser.
Naturopathix updated ZymaDerm product packaging in December and announced on March 27 that the brand's topical treatment for molluscum contagiosum is available at the majority of CVS stores.
Molluscum contagiosum, a contagious skin infection also known as "water warts" caused by a virus of the poxvirus family, is common throughout the US and around 3m children contract the infection each year, the Needham, Mass.-based firm said.
The ZymaDerm homeopathic remedy, launched in 2003, is formulated with argentum nitricum, echinacea agustifolia, fucus vesiculosus and thuja occidentalis. In a Naturopathix survey, 92% of the respondents among 346 physicians provided samples of ZymaDerm rated it as effective as existing invasive treatments while 86% were either likely or extremely likely to use the product as their preferred treatment method for molluscum.
From the editors of the Tan Sheet.