FDA Law Blog: Recent Plan B One Step approval may reignite simultaneous Rx-OTC debate
WASHINGTON — The Food and Drug Administration may soon find itself in another Plan-B-generated quandary — the complications around granting a three-year marketing exclusivity for a medicine that is both prescription-only and over-the-counter, according to an FDA Law Blog posted Sunday by Hyman, Phelps & McNamara.
At issue is the granting of three-year marketing exclusivity on an OTC new drug application when approvals of abbreviated new drug applications for prescription-only versions of the same medicine have already been approved.
"It is undisputed that, based on FDA’s representations regarding the need for additional data to support approving Plan B One Step for use without a prescription by younger age groups, [Plan B One Step manufacturer] Teva conducted actual use studies that included participation by sufficient numbers of 15 and 16 year olds," wrote Kurt Karst, author of the blog.
That additional research was critical in the FDA’s approval of expanding OTC use to younger females, Karst noted.
At question is whether or not the PLAN B One-Step NDA supplement approval "affects the approval status of generic versions of PLAN B One-Step approved under ANDAs," Karst wrote. "The NDA supplement approval seems to raise the thorny issue of simultaneous prescription and OTC marketing of the same drug," he noted. "We don’t have the answers to those questions, but resolution of whether there is a simultaneous prescription and OTC marketing issue in the first place, and then what to do about it if there is, might be an interesting side-show as the Second Circuit takes up Judge [Edward] Korman’s decision."
No comments found
New 31° Diamond Skincare Collection features microfine diamond powder
NEW YORK — Harnessing the power of the diamond is the new 31° Diamond Skincare Collection by Rene, a new cosmetics maker.
Each product within the collection contains microfine diamond powder that works to tame and heal common complexion problems, according to the company.
Get started on the pathway to better skin with the help of the 31° Diamond Detox Peeling Gel. Featuring the exfoliating and renewing properties of diamond powder, and the antioxidant rich and soothing qualities of berry extracts and flower essences, this peeling gel is designed to gently work to improve the texture of the skin for a glowing complexion.
The Sheer Coating Ampoule helps enhance the skin’s tone. It is enriched with diamond powder and ingredients such as hyaluronic acid, peptide, collagen, and vitamin B5 work to boost elasticity and hydration, lock in moisture, visibly fade spots and even out skin tone.
As for the name, the Rene 31° Diamond Skincare Collection alludes to the skin’s need for a constant temperature of 31° celsius or 87° fahrenheit, the company stated. One degree above and the skin starts to become stressed releasing oils and creating blemishes. Rene’s whole collection is dedicated to providing thermal protection by balancing the skin’s temperature for smooth and radiant looking skin.
No comments found
Murad expands Environmental Shield skin care line
EL SEGUNDO, Calif. — Murad has announced the launch of three new product additions to its Environmental Shield line: Instant Radiance Eye Cream, Advanced Active Radiance Serum and Essential-C Sun Balm Broad Spectrum SPF 35 | PA+++.
The Instant Radiance Eye Cream promises to minimize the appearance of dark circles by 30% in 15 minutes and by 48% with continued use. The Advanced Active Radiance Serum aims to improve brightness, clarity and radiance by 60% in less than one week. The Essential-C Sun Balm Broad Spectrum SPF 35 | PA+++ is a portable sun stick that provides hydration, sun spot prevention and SPF protection.
As part of Murad’s Environmental Shield line — designed for those who suffer from dark circles, age spots, sun spots and hyperpigmentation — each of these three new products feature a combination of ingredients that are meant to restore and renew environmental aging caused by sun damage, free radicals and other external stressors, while protecting it from future damage.
Instant Radiance Eye Cream is priced at $68. The Advanced Active Radiance Serum is priced at $89 and Essential-C Sun Balm Broad Spectrum SPF 35 | PA+++ is priced at $25.