Morgan Petronelli, Associate Editor

Revance Therapeutics announced the FDA will initiate its pre-approval inspection of the company’s daxibotulinumtoxinA (DAXI, Revance Therapeutics) manufacturing facility by the end of June 2021.

The company reports that in November 2020, the FDA advised Revance that it was deferring a decision on the Biologics License Application (BLA) for DAXI because the pre-approval manufacturing facility inspection could not be conducted due to COVID-19 pandemic-related travel restrictions.

Revance is seeking approval of DAXI for injection for the treatment of moderate to severe glabellar lines (GL).

1. Revance provides update on daxibotulinumtoxina for injection pre-approval inspection. BioSpace. Accessed June 4, 2021. https://www.biospace.com/article/revance-provides-update-on-daxibotulinumtoxina-for-injection-pre-approval-inspection/

Articles

Revance provides an update on the approval process for its injectable daxibotulinumtoxinA (DAXI) for the treatment of glabellar lines.

FDA to Initiate Pre-Approval Inspection of DAXI Manufacturing Facility

recent Cutaneous Connection podcast, we take a look back at what happened at the American Academy of Dermatology Virtual Meeting Experience 2021 (AAD VMX 2021), including exclusive interviews with two KOLs about their presentations regarding climate change and new data on biologics for psoriasis.

For the full catalog of past Cutaneous Connection Episodes, click 

Podcasts

We take a look back at what happened at the American Academy of Dermatology Virtual Meeting Experience 2021 (AAD VMX 2021), including exclusive interviews with two KOLs about their presentations regarding climate change and new data on biologics for psoriasis.

Recap: What Happened at ADD VMX 2021?

Videos

David Light, founder and CEO of Valisure, the independent lab that discovered the presence of a human carcinogen in multiple brands and batches of sunscreen, sits down with Aesthetic Authority discuss the reports' findings and the impact this news will have on the sun protection industry.

Valisure CEO Speaks on Controversy of Benzene in Sunscreen

Valisure, a pharmacy dedicated to batch testing medications before they reach consumers, found in a recent test that 78 different sunscreen and after-sun care products contained benzene, a human carcinogen.

According to the U. S. Center for Disease Control and Prevention (CDC), the World Health Organization (WHO), U.S. Department of Health and Human Services, and various other regulatory agencies, benzene is known to cause cancer in humans. The National Institute for Occupational Safety and Health (NIOSH) also defines benzene as a carcinogen and exposure can include “inhalation, skin absorption, ingestion, and skin and/or eye contact.” 

In a test conducted by Valisure, 27% of samples tested contained detectable benzene, while some batches contained up to 3 times the FDA concentration limit of 2 parts per million (ppm).

“There is not a safe level of benzene that can exist in sunscreen products,” said Christopher Bunick, MD, PhD, associate professor of dermatology at Yale University and member of 

’ editorial advisory board. “Even benzene at 0.1 ppm in a sunscreen could expose people to excessively high nanogram amounts of benzene.”

The company is requesting the FDA recall the identified sunscreens and after-sun care products and are asking for more defined limits for benzene contamination in cosmetic and drug products. Valisure also notes that not all sunscreen products contain benzene and urges the continued use of uncontaminated products available to help protect against ultraviolet radiation (UV).

“Benzene is one of the most studied and concerning human carcinogens known to science,” said David Light, founder and CEO of Valisure. “Its association with forming blood cancers in humans has been shown in numerous studies at trace levels of parts per million and below. The presence of this known human carcinogen in products widely recommended for the prevention of skin cancer and that are regularly used by adults and children is very troubling.” 

Click the documents below to find out which products contain and do not contain benzene, as well as tips for responsible disposal of potentially contaminated products. 

List of products where benzene was detected.

List of products where benzene was not detected.

Responsible Disposal of Potentially Contaminated Products.

1. Valisure detects benzene in sunscreen. Valisure. Published May 20, 2021. Accessed May 25, 2021. 

https://www.valisure.com/blog/valisure-news/valisure-detects-benzene-in-sunscreen/

A recent test found various brands and batches of sunscreen and after-sun care products contained benzene, a known human carcinogen. 