Lauder for supplementing monograph
This article was originally published in The Rose Sheet
Executive Summary
Sunscreen ingredients bemotrizinol and bisoctrizole should be added to FDA's OTC sunscreen monograph, Estee Lauder asserts in Nov. 1 comments to the agency, in support of time and extent applications filed by Ciba in April 2005. After reviewing the applications, FDA recommended initially that both ingredients (up to 10% each) be recommended for monograph inclusion. Then in a Dec. 5 Federal Register notice, the agency issued a call for data on bemotrizinol and bisoctrizole as single active ingredients and in combination with other active ingredients in sunscreen products (1"The Rose Sheet" Dec. 12, 2005, p. 3). "The Lauder Companies would like to offer our consumers more broad-spectrum, photostable UVA protective sunscreen products that will protect them from both UVA and UVB," Lauder states, adding: "We petition you to approve these sunscreen actives as soon as possible"...
You may also be interested in...
FDA Will Consider Triclosan For OTC Acne Monograph Inclusion
FDA is seeking data on use of triclosan in topical acne treatment products, the agency announced in a Dec. 5 Federal Register 1notice
Japan Grants Global-First Approval To Zolbetuximab, 15 Other New Drugs
Astellas's first-in class CLDN18.2-targeting antibody receives its first approval worldwide, while crovalimab and a number of drugs for rare diseases also receive nods from regulators and are now awaiting reimbursement price-listing.
Hanmi-OCI Merger Hits Wall As Brothers Win Shareholder Vote, Board Seats
The planned merger of Korea's Hanmi Pharm Group with OCI Group hits a major speed bump as the two sons of Hanmi's founder and other candidates recommended by them secture board seats. But it remains to be seen how the Lim brothers will fulfil their ambitious promises.