The United States Congress has passed the Sunscreen Innovation Act (H.R. 4250/S. 2141), which gives the Food and Drug Administration (FDA) the authority to prioritize the review and approval of more effective sunscreen ingredients that have been available to consumers outside the U.S. for several years.

The new bill amends the Federal Food, Drug, and Cosmetic Act to establish a process for the...

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The United States Congress has passed the Sunscreen Innovation Act (H.R. 4250/S. 2141...

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FDA Approves ONEXTON Gel For Acne Vulgaris

Valeant Pharmaceuticals has received U.S. Food and Drug Administration (FDA) approval for ONEXTON Gel (clindamycin phosphate and benzoyl peroxide, 1.2%/3.75%), for the once-daily treatment of comedonal (non-inflammatory) and inflammatory acne in patients 12 and older.

In a pivotal trial with 498 patients with moderate to severe acne, ONEXTON Gel reduced noninflammatory lesions by a mean of 52% vs. 28% vehicle and reduced inflammatory lesions by a mean of 60% vs. 31% vehicle. In addition, the proportion of patients experiencing treatment success—defined as at least two grade improvement in the Evaluator Global Severity (EGS) score from baseline—was twice that of vehicle (35% vs. 17%).

In the controlled clinical trial, less than 1% of patients experienced a treatment-related adverse event. The most common adverse events were: burning sensation (0.4%), dermatitis contact (0.4%), pruritus (0.4%) and rash (0.4%). No patient discontinued treatment due to any adverse event.

“We are very pleased that the FDA has approved this new dual action medication that gives physicians and patients a new option for the topical treatment of acne vulgaris,” said J. Michael Pearson, chairman and CEo of Valeant. “ONEXTON is the...

Retinoids Effective in Reducing Melasma

A new topical product featuring a combination of retinoids offers results comparable to hydroquinone in patients with facial melasma. Maria Teresa Truchuelo MD, PhD, Natalia Jimenez, MD, and Pedro Jaen, MD, PhD, of the dermatology department at University Hospital Ramon y Cajal in Madrid, Spain, performed a prospective, double-blind, vehicle-controlled, and randomized study in 30 patients with melasma. Sibjects applied the combination retinoid product on one side of their faces and the vehicle on the other. Product was applied twice daily for three months.

The researchers used standardized photographs taken at baseline, 1 ½ months and 3 months to measure outcomes. The main variable to determine the efficacy was improvement of the hemifacial Melasma Area Severity Index (MASI). The authors also gauged improvement perceived by the investigator, improvement perceived by the patient, impact on quality of life and side effects.

After 3 months, the treated side improved significantly vs. the vehicle side, reaching an improvement of 70%, which the authors note is comparable to the percentage of improvement described with hydroquinone. No notable side effects were detected. The study was published in the Journal of...

Congress Passes Sunscreen Innovation Act

The United States Congress has passed the Sunscreen Innovation Act (H.R. 4250/S. 2141), which gives the Food and Drug Administration (FDA) the authority to prioritize the review and approval of more effective sunscreen ingredients that have been available to consumers outside the U.S. for several years.

The new bill amends the Federal Food, Drug, and Cosmetic Act to establish a process for the review and approval of over-the-counter (OTC) sunscreen active ingredients. It allows any person to request that the Secretary of Health and Human Services (HHS) determine whether an OTC sunscreen active ingredient or combination of ingredients is safe and effective and requires the director of the Center for Drug Evaluation and Research to complete a review of a filed request and determine the safety and efficacy of the sunscreen active ingredient or combination of ingredients within 300 days.

Since 2002, eight new sunscreen applications have been filed and are still awaiting review 12 years later. Once signed by the President, the bipartisan Sunscreen Innovation Act would streamline the approval process for new sunscreen ingredients to ensure that new ingredients and products receive a transparent review within a...