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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
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

In this issue:

  1. An Update on New and Emerging Options for the Treatment of Vitiligo
  2. Drug Treatments for Skin Disease Introduced in 2007
  3. Update on Drugs and Drug News - March 2008