Galderma Laboratories, L.P.â€™s has announced that healthcare providers may now write prescriptions for Tri-LumaÂ® Cream (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%). This is the only FDA-approved triple combination topical product indicated for the short-term (up to 8 weeks) treatment of moderate to severe melasma of the face, and it is now available in pharmacies.
Tri-LumaÂ®Â Cream contains three active ingredients: fluocinolone acetonide 0.01%, a mild corticosteroid that reduces inflammation; hydroquinone 4%, a de-pigmenting agent that interrupts the formation and synthesis of melanin to help lighten the skin; and tretinoin 0.05%, which works to increase the skin cell turnover rate to exfoliate skin. There is no generic equivalent.
Perrigo and Clobetasol Emulsion Propionate Foam, 0.05%
Perrigo Company has announced that it has launched clobetasol emulsion propionate foam, 0.05%, the generic equivalentÂ of OluxÂ® -E Foam, 0.05%. Perrigo will commence shipment of the product immediately. As Perrigo was the first generic filer against this product, it has 180 days of generic exclusivity. The launch date was agreed upon in a 2012 litigation settlement between Perrigo and GlaxoSmithKline.
Clobetasol emulsion propionate foam, 0.05% is indicated for the treatment of moderate to severe dermatosis of the scalp.
Glenmark Generics Receives ANDA for Mupirocin Calcium Cream
Glenmark Generics Ltd., has obtained final abbreviated new drug approval (ANDA) from the FDA for Mupirocin Calcium Cream USP, 2%. Mupirocin Calcium Cream is indicated for the treatment of secondarily infected traumatic skin lesions due to susceptible strains of S.aureus and S.pyogenes. Glenmark plans to begin shipping immediately.
FDA Approves First Topical Acne Treatment in Children Aged 9 and Up
The FDA has approved the topical acne drug adapalene 0.1%/benzoyl peroxide 2.5% (Epiduo, Galderma) in children ages 9 and older.
Epiduo had already been approved for acne treatment in children aged 12 years and older. FDAâ€™s more recent approval was based on data from a 12-week, multicenter, randomized, vehicle -controlled, double-blind study of pediatric patients aged 9 to 11 years. The topical treatment was found to be safe and effective, with nearly 70% of patients demonstrating improvement in acne, compared to 23% in patients treated with placebo.
Mylan Launches First Generic Version of Zovirax
Mylan Pharmaceuticals has announced that it received final approval from the FDA for its Abbreviated New Drug Application (ANDA) for Acyclovir Ointment USP, 5%. This is the first generic version of Valeant Internationalâ€™s ZoviraxÂ®Â Ointment, which is indicated in the management of initial genital herpes and in limited non-life-threatening mucocutaneous herpes simplex virus infections in immunocompromised patients. Mylan is shipping this product immediately.
BTL Aesthetics Launches Exilis Elite
BTL AestheticsÂ has announced the introduction of Exilis ELITEâ„¢, its next stage device for reducing wrinkles and treating skin laxity of the face and body. The Exilis ELITE was re-engineered to provide faster and safer face and body rejuvenation in fewer treatment sessions.
Optimizing the dynamic monopolar radiofrequency (RF) technology of the original Exilis system, the new ELITE improves the delivery of thermal energy for measurable results after only two to three treatments. According to the company, this level of clinical efficacy is achieved by delivering maximum power and speed of high frequency radio waves using BTLâ€™s proprietary Energy Flow Controlâ„¢ and Impedance Intelligenceâ„¢. These features are designed to provide uniform and precise distribution of heat to the entire treatment area while ELITEâ€™s advanced cooling allows for layering of RF energy at various depths.
A multi-center clinical study to validate a two-treatment protocol will be performed at three test sites. At each of the three test sites, 12 to 15 patients with wrinkles and skin laxity in the mid to lower face will be treated two times at a three to four week interval.
Biopelle launches New, Exclusive Formulations and Introduces the Brand biopelle
Biopelle, Inc. officially announced today a combination of a launch of new products as well as a re-introduction of existing products in uniform brand categorization, all under the new brand name biopelle. Delivering a range of products essential to physician-provided skin care, biopelle uses evidence-based ingredients, enhanced by unique, patented technologies.