Drug Treatments for Skin Disease Introduced in 2004

Drug Class	Generic/Trade Company Names	Indication	Approving Regulatory Agency
Antiacne Agent	Clindamycin Foam 1% Evoclin® Connetics	Approved for topical application in the treatment of acne vulgaris	US FDA
Antibacterial Agent	Cefdinir Oral Suspension Omnicef® Abbott Laboratories	A new 250mg/5ml dosing option approved for use in pediatric patients 6 months to 12 years of age. This more concentrated form allows parents to administer fewer teaspoons/ dose to their children.	US FDA
	Clindamycin Evoclin® Foam 1% Connetics	Approved for the treatment of mild-tomoderate acne vulgaris. Evoclin® was formerly referred to as Actiza™.	US FDA
Antihistamine	Desloratadine Syrup CLARINEX® Schering-Plough	Approved for the relief of symptoms associated with seasonal allergic rhinitis in children >2 years of age, and perennial allergic rhinitis and chronic idiopathic urticaria, or hives of unknown cause in children as young as 6 months of age.	US FDA
Antipruritic Agent	Cetirizine HCl Zyrtec® Pfizer/UCB Pharma	A new chewable formulation approved for the treatment of seasonal and perennial allergic rhinitis and chronic idiopathic urticaria in children >2 years of age.	US FDA
Antipsoriatic Agent	Alefacept Amevive® Biogen Idec	Approved for the treatment of adult patients with moderate-to-severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.	Israeli Ministry of Health Therapeutic Goods Administration— Australia TPP Canada
	Efalizumab Raptiva® Serono	Approved for the treatment of adult patients with moderate-to-severe chronic plaque psoriasis.	Swissmedic CHMP Europe
	Etanercept Enbrel® Amgen/Wyeth Pharmaceuticals	Approved for the treatment of moderate-tosevere plaque psoriasis who failed to respond to, or have a contraindication to, or are intolerant of other systemic therapy.	US FDA CHMP Europe
Dermal Filler	Hyaluronic Acid Filler Hyalite™ Mentor	Approved for soft tissue augmentation in the correction of wrinkles and folds and for lip enhancement.	CHMP Europe
	Hyaluronic Acid Filler RESTYLANE® Medicis	Approved for the correction of moderate-tosevere facial wrinkles and folds.	US FDA
	Hylan-B Gel Hylaform Inamed/Genzyme	Approved for injection into the mid-to-deep dermis for correction of moderate-to-severe facial wrinkles and folds.	US FDA
	Injectable Poly-L-Lactic Acid Sculptra Dermik Laboratories	Approved for the correction of lipoatrophy in people with HIV infection.	US FDA
Enzyme Replacement Therapy	Agalsidase Alfa Replegal™ Transkaryotic Therapies	Approved for the treatment of Fabry disease under its Notice of Compliance with Conditions Policy, under which Transkaryotic Therapies can market this product while conducting post-marketing studies	TPP Canada
Immunomodulatory Agent	Imiquimod Cream 5% Aldara® 3M Pharmaceuticals	Approved for clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses on the face or scalp in immunocompetent adults.	US FDA TPP Canada
	Imiquimod Cream 5% Aldara® 3M Pharmaceuticals	Approved for the treatment of biopsyconfirmed, primary superficial basal cell carcinoma in adults with normal immune systems.	US FDA TPP Canada
Medical Device	Clinical Phototherapy System ClearTouch™ Light Unit Assembly Radiancy	Approved for the treatment of pustular inflammatory acne.	US FDA
	Ultrasonic Skin Permeation Device SonoPrep® Sontra Medical	Approved for use with topical lidocaine.	US FDA
Monoclonal Antibody	SGN-30 Seattle Genetics	Granted Orphan Drug Designation for the treatment of T-cell lymphomas.	US FDA
Neurotoxin	Botulinum Toxin – Type A BOTOX® Allergan	Additional indication approved for the treatment of severe primary axillary hyperhidrosis that is inadequately managed with topical agents.	US FDA
Oncologic Agent	MDX-010 Medarex	Granted Orphan Drug Designation for the treatment of high-risk Stage II, Stage III, and Stage IV melanoma.	US FDA
Psoriatic Arthritis Agent	Leflunomide Arava® Aventis	A new indication approved for the treatment of adult patients with active psoriatic arthritis.	CHMP Europe
	Etanercept Enbrel® Amgen/Wyeth Pharmaceuticals	Approved for the treatment of psoriatic arthritis.
	Etanercept Enbrel® Amgen/Wyeth Pharmaceuticals	New dosing formula approved for the treatment of psoriatic arthritis and moderateto- severe plaque psoriasis – a prefilled syringe that will eliminate the need to mix the drug prior to injecting and will allow most patients receiving this drug to take only one injection/week instead of the two 25mg injections currently used weekly by patients.	US FDA
	Infliximab REMICADE® Schering-Plough/Centocor	Approved for use in combination with methotrexate for the treatment of active and progressive psoriatic arthritis in patients who have responded inadequately to diseasemodifying antirheumatic drugs.	CHMP Europe

1. Table of Contents
2. Mycophenolate Mofetil: A Dermatologic Perspective
3. Drug Treatments for Skin Disease Introduced in 2004
4. Twelve Technical Strategies to the Perfect Surgical Scar
5. Update on Drugs and Drugs News