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Drug Treatments for Skin Disease Introduced in 2008

Drug Class	Generic/Trade Company Names	Indication	Approving Regulatory Agency
Actinic Keratosis	Methyl Aminolevulinate HCl Cream Metvixia™ + Aktilite® CL128 Photocure ASA/ Galderma	Approved for the treatment of actinic keratosis.	US FDA
Antiacne Agents	Adapalene 0.1% Differin® Gel Galderma KK/ Schionogi	Approved for the treatment of acne vulgaris.	Japan’s Ministry of Health, Labour & Welfare
Antiacne Agents	Clindamycin Phosphate 1.2% + Benzoyl Peroxide 2.5% Acanya® Gel Arcutis Pharmaceuticals	Approved for the once daily treatment of both noninflammatory and inflammatory acne lesions in patients 12 years of age and older.	US FDA
Antibacterial Agent	Ceftobiprole Medocaril IV ZEFTERA® Basilea Pharmaceuticals	Approved for the treatment of complicated skin and soft tissue infections, including diabetic foot infections. In Switzerland, this includes nonlimb- threatening diabetic food infections without concomitant osteomyelitis.	Health Canada, Swissmedic
Anticancer Agent	Denileukin Diftitox Ontak® Esai Corporation	Approved for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma whose malignant cells express the CD25 component of the IL-2 receptor (CD25+).	US FDA
Antihistamine	Loratadine Claritin® Schering-Plough	Approved labeling change to advise consumers that this OTC formulation relieves allergy symptoms caused by both perennial and seasonal allergies.	US FDA
Antipruritic Agent	Levocetirizine Dihydrochloride 0.5mg/ml Oral Solution Xyzal® UCB & sanofi aventis	Approved for the relief of symptoms associated with indoor and outdoor allergies, and for chronic idiopathic urticaria.	US FDA
Antipsoriatic Agents	Adalimumab Humira® Abbott Laboratories	Approved for the treatment of adults with moderateto- severe chronic plaque psoriasis, who are not suitable candidates for other systemic therapies.	US FDA
	Calcipotriene 0.005% + Betamethasone Dipropionate 0.064% Topical Suspension Taclonex Scalp® / Xamiol® Gel Warner Chilcott / LEO Pharma	Approved for the once daily treatment of moderateto- severe psoriasis vulgaris of the scalp in adults 18 years of age or older. It is being marketed as Taclonex Scalp® (Warner Chilcott) in the US and Xamiol® (Leo Pharma) in Canada and Europe.	US FDA, EMEA, Health Canada
	Calcipotriene 0.005% Topical Solution Nycomed US, Inc./ Fougera	Generic formulation approved for the topical treatment of chronic, moderately severe psoriasis of the scalp.	US FDA
	Etanercept Enbrel® Wyeth	Approved in a 50mg once weekly dosage regimen as an alternative to the currently approved 25mg twice weekly regimen for the treatment of moderate-tosevere plaque psoriasis.	EMEA
	Ustekinumab Stelara® Janssen-Ortho	Approved for adults with moderate-to-severe plaque psoriasis.	Health Canada
Crohn’s Disease	Certolizumab Pegol Cimzia® UCB S.A.	Approved for the treatment of adults with moderateto- severe Crohn’s Disease who are inadequate responders to conventional therapies.	US FDA
Crohn’s Disease	Natalizumab TYSABRI® Elan Corp. / Biogen Idec	Approved for inducing and maintaining clinical response and remission in adult patients with moderately to severely active Crohn’s Disease (CD) with evidence of inflammation. Indicated for patients who are an inadequate responders to, or are able to tolerate, conventional CD therapies and TNF-alpha inhibitors.	US FDA
Dermal Filler	Hyaluronic Acid Gel + Lidocaine Prevelle Silk™ Mentor Corporation/Genzyme Corporation	Approved for the reduction of moderate-to-severe facial lines, folds, and wrinkles.	US FDA
Hand Eczema	Alitretinoin Toctino® Basilea Pharmaceuticals	This once daily, oral treatment was approved for adults with severe, chronic hand eczema that is unresponsive to potent topical corticosteroids.	Danish Medicines Agency, French Regulatory Authority
HIV/AIDS	Atazanavir Sulfate REYATAZ® Bristol-Myers Squibb	Approved as part of a combination therapy in treatment naïve HIV-1 infected adult patients. This 300mg once daily formulation to be boosted with ritonavir 100mg once daily.	US FDA
	Etravirine Intelence™ Tibotec Therapeutics	Approved for the treatment of HIV infected adults who have failed other antiretroviral therapies. For use in combination with other antiretroviral agents.	US FDA
	Maraviroc SELZENTRY® Pfizer	Approved for use in treatment-experienced adults with CCR5-tropic HIV in combination with other antiretroviral agents.	US FDA
	Tipranavir Aptivus® Boehringer-Ingelheim	Approved with dosing information for treatmentexperienced pediatric patients aged 2-18 years who are infected with HIV. The recommended dose for both the capsules and oral solution is 14mg/kg with 6mg/kg ritonavir, or 375mg/m2 tipranavir coadministered with 150mg/m2 ritonavir. Prescribers should calculate the appropriate dose for each child based on body weight (kg) or body surface area (m2) and should not exceed the recommended adult dose of 500mg coadministered with 200mg ritonavir twice daily.	US FDA
Hypotrichosis	Bimatoprost Ophthalmic Solution LATISSE® 0.03% Allergan	Approved once daily for hypotrichosis of the upper eyelashes. To maintain the effect, once daily continued treatment is required.	US FDA
Vaccines	Shingles Vaccine Zostavax® Merck Frosst	Approved for the prevention of shingles in individuals aged 60 years or older.	Health Canada
Vaccines	HPV Vaccine Gardasil® Merck & Co.	An additional indication was approved, including the prevention of vaginal and vulvar cancer caused by HPV types 16 and 18 in girls and women aged 9-26 years.	US FDA

In this issue:

Rosacea and Its Topical Management
Drug Treatments for Skin Disease Introduced in 2008
Update on Drugs and Drug News - February 2009

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