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Update on Drugs and Drug News: September 2010


Name/Company Approval Dates and Comments

Clindamycin phosphate 1.2% + tretinoin 0.025%
Veltin™ gel
Stiefel Laboratories, Inc./GSK

The US FDA approved a topical combination of clindamycin phosphate and tretinoin in July 2010 for the treatment of acne vulgaris in patients 12 years of age and older. The aqueous gel vehicle incorporates an antibiotic and a retinoid in a fixed combination. Recommended application is once daily in the evening to the affected area.

Minocycline hydrochloride extended release tablets
Mylan Inc./Matrix Laboratories Limited

The US FDA approved minocycline hydrochloride extended release tablets (45mg, 90mg, and 135mg) in July 2010 for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris. This oral antibiotic is a generic version of Solodyn® (Medicis Pharmaceuticals Corporation).

Correction: Due to an editing error in Skin Therapy Letter 15(7):8 (July-August 2010), the drug name was misstated as famciclovir, when in fact it should have been adapalene 0.1% gel.

Adapalene 0.1% gel
TEVA Pharmaceutical Industries

The US FDA approved a generic version of adapalene 0.1% gel (comparable brand, Differin®, Galderma) in June 2010 for the treatment of acne.


Drug News

Dillner, et al.* reported that the quadrivalent human papillomavirus (HPV) vaccine (Gardasil™, Merck and Co, Inc.) provides sustained protection against low-grade lesions that are associated with HPV types contained in the vaccine. Investigators examined data from two trials involving 17,622 women aged 16 to 26 years, who were randomized to receive three doses of quadrivalent HPV vaccine for serotypes 6, 11, 16, and 18 or placebo for assessment of the vaccine’s efficacy and durability in preventing low-grade cervical, vulvar and vaginal intraepithelial neoplasias, and condyloma acuminata (anogenital warts). The results reported were derived from 42 months of follow-up. Researchers found the quadrivalent vaccine to be 96% effective against grade I cervical intraepithelial neoplasia, 100% protective for both grade I vulvar and vaginal intraepithelial neoplasia, and 99% effective against condyloma. The vaccine also demonstrated efficacy against any lesion regardless of HPV type (in HPV naïve women): 30% for cervical neoplasia, 75% for vulvar neoplasia, 48% for vaginal neoplasia, and 83% for condyloma.

*Dillner J, et al. BMJ 341:c3493 (2010).

In June 2010, calcitriol (vitamin D3) ointment (Silkis™, Galderma Canada Inc.) was introduced in Canada for the treatment of mild to moderately severe plaque psoriasis in adults with up to 35% of body surface area involvement. It is recommended that not more than 35% of the body surface should be exposed to daily treatment. Daily dosing should not exceed 30g. The product was US FDA approved in 2009 under the trade name of Vectical™.

Recently in Canada, Pediapharm Inc. announced the launch of EpiCeram®, a new steroid-free, ceramide-dominant topical therapy for the improvement of skin barrier abnormalities in atopic dermatitis (AD). The prescription-only formulation includes high concentrations of three lipids (ceramides, cholesterol, and free fatty acids) and 5% petrolatum. Use is recommended for AD patients =6 months of age. EpiCeram® is indicated for the management and relief of burning and itching associated with various dermatoses, including atopic dermatitis, irritant contact dermatitis, and radiation dermatitis. Approval was granted by Health Canada in September 2009. It was launched in the US in October 2008 by Promius Pharma.


In this issue:

  1. Nanodermatology: A Bright Glimpse Just Beyond the Horizon - Part I
  2. The Management of Chronic Pruritus in the Elderly
  3. Update on Drugs and Drug News: September 2010