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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

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

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 naďve 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

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:

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