FDA Approves Xeomin (incobotulinumtoxinA)
Merz Aesthetics has announced that the FDA has approved XEOMIN (incobotulinumtoxinA) for temporary improvement in the appearance of moderate-to-severe glabellar lines.
XEOMIN is approved for the temporary improvement of the appearance of glabellar lines in 14 countries in the European Union (EU), including Germany, the United Kingdom, France, Italy and Spain under the brand name BOCOUTURE.
XEOMIN will be available nationwide to physicians in the spring of 2012.
Cleure Launches FDA-Approved Broad-Spectrum Sunscreen
Cleure has launched a broad-spectrum facial sunscreen for sensitive skin, Cleure Natural Sunscreen. The new sunscreen adheres to new FDA guidelines, but is also formulated specifically
for sensitive skin as well as individuals with chemical sensitivities and allergies.
This launch is timed to coincide with the FDA's new guidelines and restrictions for sunscreen manufacturers. The FDA is now mandating that sunscreen manufacturers test their products against both ultraviolet A (UVA) and ultraviolet B (UVB) rays before the product can be labeled broad-spectrum.
ROGAINE
New Men's ROGAINE® Unscented Topical Foam is the same clinically proven, easy-to-use foam that regrew hair in 85 percent of men with twice-daily use. ROGAINE® quickly penetrates into the scalp to revitalize hair follicles that have become dormant and stimulate hair growth. Market research has shown that 57 percent of current ROGAINE® users wished the product was unscented and 51 percent used the product less frequently due to the fragrance. ROGAINE® removed the fragrance to encourage better consumer usage.
Eucerin Launches Campaign in Europe and Asia
In July, Eucerin launched its DermoPURIFYER series, designed to fight acne, in parts of Europe and Asia. Eucerin touts the series
as perfect for use both as medical skin treatment for acne lesions and adjunctive skin treatment after undergoing medical
treatment. The campaign looks to inspire acne sufferers to talk with their dermatologists about their trouble with acne.
Graceway Receives FDA Approval for Zyclara Cream 2.5%
Graceway Pharmaceuticals, LLC (Graceway) has announced that the FDA has approved Zyclara® Cream, 2.5% for the treatment of actinic keratoses, determining it to be safe and effective for the treatment of clinically typical, visible or palpable
actinic keratoses (AK). The new formulation may be used on the full face or balding scalp in a convenient six-week dosing
cycle. The lower concentration is designed to offer greater tolerability while maintaining the efficacy that has long been associated with imiquimod
FDA Approves First Generic Versions of Levofloxacin
The FDA has approved applications from 12 companies to manufacture generic versions of levofloxacin (Levaquin, Ortho-McNeil-Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson), a widely used fluoroquinolone antibiotic.
The companies, including Teva Pharmaceutical and Sandoz, Inc., will start producing generic tablets, oral solution and injectable solution formulations of levofloxacin now that Johnson
& Johnson's patent has expired.
In 2008, the FDA issued a black box warning for all fluoroquinolones
alerting prescribers and patients that these products are associated with an increased risk of tendinitis and tendon rupture.
According to the FDA's warning, the risk for tendon rupture "is greater in older people, especially in those older than 60, in patients taking corticosteroid drugs, and in those with kidney, heart, or lung transplants." The warning also notes that the drug may cause muscle weakness in patients with myasthenia gravis, a chronic autoimmune neuromuscular disease.
