Written for dermatologists by dermatologists. Indexed by the US National Library of Medicine.

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Drug Treatments for Skin Disease Introduced in 2007

Drug Class	Generic/Trade Company Names	Indication	Approving Regulatory Agency
Antiacne Agents	Adapalene Gel 0.3% Differin® Galderma Laboratories	Approval granted for a higher concentration formulation of this topical retinoid for the treatment of moderate-to-moderately severe acne.	US FDA
	Drospirenone/ Ethinyl Estradiol Yaz® Berlex Inc.	A new indication approved for the treatment of moderate acne vulgaris in women wanting an oral contraceptive for birth control.	US FDA
	Tretinoin 0.05% Gel Anthralin® Galderma Laboratories	Approved this topical retinoid for the treatment of acne vulgaris.	US FDA
Antibacterial Agents	Daptomycin for Injection CUBICIN® Cubist Pharmaceuticals	Approved for the additional indications of right-sided infective endocarditis (RIE) due to Staphylococcus aureus and Staphylococcus aureus bacteremia, when associated with RIE or with complicated skin and soft-tissue infections.	EMEA
	Retapamulin Ointment 1% Altabax® GlaxoSmithKline	Approved for the topical treatment of impetigo due to susceptible strains of Staphylococcus aureus or Streptococcus pyogenes. This product is the first in a new class of prescription topical antibacterials to be used twice daily for a 5-day period in patients =9 months.	US FDA
	Tinidazole Tablets Tindamax® Mission Pharmacal	Approved for the treatment of bacterial vaginosis. This oral medication provides a shorter treatment course, requires fewer doses, as well as exhibits an improved tolerability profile than current therapies.	US FDA
Antifungal Agents	Ciclopirox Topical Solution 8% Perrigo Company	Approval granted for the treatment of mild-to-moderate fungal infections of the nails. This nail lacquer is considered to be the therapeutic equivalent of Penlac® (sanofi-aventis).	US FDA
	Ketoconazole 2% Foam Extina® Stiefel Laboratories	Approved for the topical treatment of seborrheic dermatitis in immunocompetent patients =12 years of age. The novel vehicle delivery system (VersaFoam® HF® Technology) has been shown to improve absorption and drug distribution.	US FDA
	Terbinafine Hydrochloride Lamisil® Novartis Pharmaceuticals	Approved for the treatment of tinea capitis in children =4 years of age. This new granular formulation, which can be sprinkled on food, is intended to improve patient compliance and treatment outcomes.	US FDA
Antihistamines	Desloratadine Aerius®/ Azomyr®/ Neoclarityn® Schering-Plough	Two new formulations of this antihistamine were approved. orodispersible tablets for the treatment of symptoms associated with allergic rhinitis and chronic idiopathic urticaria (CIU) in adults and children =6 years of age; oral solution for the treatment of symptoms associated with allergic rhinitis and CIU in adults and children =1 year of age.	EMEA
	Levocetirizine Dihydrochloride Xyzal® UCB/ sanofi-aventis	Approved for the relief of symptoms associated with seasonal and perennial allergic rhinitis and uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children =6 years of age.	US FDA
	Loratadine Dry Syrup 1% Claritin® Shering-Plough	Approved for the treatment of allergic rhinitis, urticaria and pruritus associated with skin diseases in children =3 years of age. The dry syrup granule formulation is presently only available in Japan.	MHLW/KIKO Japan
Antimicrobial Agents	Nanocrystalline Silver Cream NPI 32101 Nucryst Pharmaceuticals	Approved for broad spectrum protection against microbes including strains resistant to MRSA, such as Pseudomonas aeruginosa and Staphylococcus aureus.	US FDA
Antipsoriatic Agents	Adalimumab HUMIRA® Abbott Laboratories	Approved for the treatment of moderate-to-severe plaque psoriasis.	EMEA
Antiviral Agent	Famciclovir TEVA Pharmaceutical Industries	Approval granted to the first generic formulation of famciclovir for the treatment of herpes zoster (shingles).	US FDA
Atopic Dermatitis/ Eczema	Clobetasol Propionate 0.05% Olux-E™ Foam Stiefel Laboratories	Approved for the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses (psoriasis and eczema) in patients =12 years of age.	US FDA
Crohn’s Disease	Adalimumab Humira® Abbott Laboratories	Approved as a treatment for reducing the signs and symptoms and inducing and maintaining clinical remission in adults with moderately-to-severely active Crohn’s disease who have had an inadequate response to conventional therapy.	US FDA EMEA
Crohn’s Disease	Infliximab Remicade® Centocor/ Schering-Plough	Approved for a new indication that includes the treatment of severe, active Crohn’s disease in pediatric patients aged 6-17 years who are nonresponsive to conventional therapy (i.e., a corticosteroid, or an immunomodulator) and primary nutrition therapy, or who are intolerant to, or have contraindications for such therapies.	EMEA
Dermal Fillers	Hyaluronic Acid Gel Particles Perlane® Medicis	Approved for implantation into the deep dermis to the superficial subcutis for the correction of moderate-to-severe facial folds and wrinkles, such as nasolabial folds.	US FDA
	Hyaluronic Acid Injectable Soft Tissue Filler ELEVESS® Anika Therapeutics / Galderma	Approved as a soft tissue filler for the treatment of facial wrinkles and scar remediation.	US FDA
	Cross-Linked Hyaluronic Acid Injectable Gel Juvéderm™ Ultra; Juvéderm™ Ultra Plus Allergan, Inc.	Approval of label extensions following submission of new clinical data that demonstrated that duration of benefit for both products may last up to 1 year.	US FDA
HIV	Lopinavir/ Ritonavir Kaletra® Abbott Laboratories	Approved a lower-strength tablet formulation (lopinavir 100mg + ritonavir 25mg) for pediatric HIV patients weighing >15kg who are able to swallow the intact tablet.	US FDA
	Maraviroc Selzentry® Pfizer, Inc.	Approved for use in combination with other antiretroviral drugs for the treatment of adults with CCR5-tropic HIV-1, who have been treated with other HIV medications and who have evidence of elevated levels of HIV in their blood.	US FDA
	Raltegravir Tablets Isentress® Merck & Co., Inc.	Approval granted to this integrase inhibitor for the treatment of HIV-1 infection; to be used in combination therapy with other antiretroviral agents.	US FDA
Oncologic Agent	Rose Bengal Disodium 10% PV-10 Provectus Pharmaceuticals	Orphan Drug designation was granted to this anti-cancer drug for the treatment of metastatic melanoma.	US FDA
Vaccines	Cervical Cancer Vaccine Cervarix® GlaxoSmithKline	Approved for the prevention of cervical cancer and precancerous lesions associated with the most common cancer causing human papillomavirus types in females 10-45 years of age.	TGA Australia
	Smallpox Vaccine ACAM2000™ Acambis PLC	Approved for protection against smallpox. This vaccine is intended for the inoculation of high-risk individuals and could be used to protect vulnerable populations in the event of a bioterrorist attack.	US FDA
	Vaccinia Immune Globulin Intravenous (Human) Cangene Corporation	Approved for counteracting certain complications associated with smallpox vaccination.	TPD Canada

Drug Treatments for Skin Disease Introduced in 2007

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