Drug Class Generic/Trade Company Names Indication Approving Regulatory Agency
Actinic
Keratoses
Aminolevulinic Acid Hcl Topical Solution
Levulan® Kerastick®
DUSA Pharmaceuticals/
Stiefel Laboratories
Approved for the treatment of precancerous actinic keratoses. ANVISA
Brazil
Imiquimod
Aldara®
Graceway
Approval for expanded indication to include treatment of clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratosis in adults. EMEA
Diclofenac Sodium 3% Gel
Solaraze®
SkyePharma
Approved for the treatment of actinic keratosis. TGA
Australia
Anesthetic
(Topical)
Lidocaine 7% & Tetracaine 7% Cream
S-Caine®
ZARS Pharma
Approved as a topical local anesthetic for use on intact skin before various superficial dermatological procedures such as dermal filler procedures, pulsed dye laser therapy, facial laser resurfacing, and laser-assisted tattoo removal. Indicated for use in adults. US FDA
Antiacne Clindamycin Phosphate 1.2% & Tretinoin 0.025% Gel
Ziana™
Medicis/Dow Pharmaceutical
Approved as the first and only combination product of clindamycin and tretinoin for the once daily treatment of acne vulgaris in patients 12 years of age or older. US FDA
Antiaging Treatments Calcium Hydroxylapatite Microspheres in Water-based Gel
Radiesse®
BioForm Medical
Approved for long-lasting correction of moderate-to-severe facial wrinkles and folds such as nasolabial folds. A second US FDA approval was granted for the long-lasting correction of facial fat loss (lipoatrophy) in patients with HIV. US FDA
Hyaluronic Acid Dermal Filler
Juvéderm™ Injectable Gel
Allergan
Approval for the treatment of facial wrinkles and folds. US FDA
Polymethylmethacrylate/ Bovine Collagen
ArteFill®
Artes Medical
This injectable implant was approved for the correction of facial wrinkles, folds, or smile lines. It is a nonresorbable dermal filler containing homogeneous precision-filtered microspheres suspended in purified collagen gel and 0.3% lidocaine to alleviate discomfort during injection. US FDA
Antibacterial/ Antibiotic
Agents
Cephalexin Capsules
Keflex®
Advancis Pharmaceutical
Approval letter issued by the US FDA to market two new strengths (333mg and 750mg) of the antibiotic capsules. Indicated to treat otitis media and infections of the respiratory tract, skin and skin structure, bone and genitourinary tract. US FDA
Retapamulin Ointment 1%
Altabax™
GlaxoSmithKline
The US FDA issued an approvable letter for this topical antibacterial for the treatment of secondarily-infected traumatic lesions that are most commonly caused by Staphylococcus aureus and Streptococcus pyogenes. US FDA
Tigecycline
Tygacil®
Wyeth
Approved for the treatment of complicated infections of the skin, soft tissue, and intra-abdominal infections acquired in the hospital or community. EMEA
Antihistamines Fexofenadine Hydrochloride Oral Suspension
Allegra®
Sanofi-Aventis
The US FDA approved this twice daily treatment that provides non-impairing relief of symptoms related to seasonal allergies in children 2-11 years of age and for chronic idiopathic urticaria in children 6-11 years of age. US FDA
Antimicrobial Agents Antimicrobial Barrier Dressing
Acticoat™ Moisture Control with SILCRYST™ Nanocrystals
Nucryst Pharmaceuticals
This foam dressing was approved for the treatment of wounds with light-to-moderate exudates for up to 7 days. EMEA
Antipsoriatic Agents Calcipotriene/Betamethasone Dipropionate
Taclonex®
Warner Chilcott/Leo Pharma
Approved for the treatment of psoriasis vulgaris in adults. US FDA
Etanercept
Enbrel®
Amgen/Wyeth
Approved for the treatment of moderate-to-severe psoriasis in adults. Previously approved indications include rheumatoid arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. TPD Canada
Infliximab
Remicade®
Schering-Plough
Approved for the treatment of moderate-to-severe psoriasis and psoriatic arthritis. TPD Canada
Infliximab
Remicade®
Centocor
Approved for the treatment of adult patients with chronic severe plaque psoriasis who are candidates for systemic therapy when other systemic therapies are not suitable. US FDA
Antiviral
Agents
Zoster Vaccine Live
Zostavax®
Oka/Merck
Approved for the prevention of herpes zoster (shingles) in people 60 years of age and older. Zostavax® is a live, attenuated varicella-zoster virus (VZV) vaccine and is given subcutaneously as a single dose of 0.65mL. US FDA
Quadrivalent Human Papillomavirus Vaccine
(Types 6, 11, 16, 18)
Gardasil®
Merck
Approved for use in females aged 9 to 26 years of age for the prevention of cervical cancer, vulvar and vaginal pre-cancers, low-grade and pre-cancerous lesions and genital warts. US FDA
TPD Canada
EMEA
Famciclovir Single-Day
Famvir®
Novartis
Approval of supplemental new drug application (sNDA) for famciclovir tablets as a single-day treatment for immunocompetent patients with recurrent genital herpes or cold sores. US FDA
Green Tea Extract
Polyphenon® E Ointment 15%
MediGene AG/ Bradley
Approved for the topical treatment of external genital and perianal warts. The active ingredient is a concentrate of catechines with a defined composition, extracted from green tea leaves. US FDA
Atopic Dermatitis/Eczema Desonide Foam 0.05%
Verdeso™
Connectics
Approved for the treatment of mild-to-moderate atopic dermatitis. US FDA
Desonide Gel 0.05%
Desonate™
SkinMedica
Approved for the treatment of mild-to-moderate atopic dermatitis in patients aged 3 months and older for up to 4 consecutive weeks. DesonateTM is a low-potency topical steroid formulated in a proprietary water-based vehicle. The formulation can be used on hair-bearing and non-hair-bearing skin. US FDA
Pimecrolimus
Elidel® Cream
Novartis
Labelling changes approved by the FDA include: a boxed warning about possible risk of cancer; recommendation as second-line treatments; and not recommended for use in children under 2 years of age. US FDA
Tacrolimus
Protopic® Ointment
Astellas
US FDA
Miconazole Nitrate 0.25%,
Zinc Oxide 15%,
White Petroleum 81.35%
Vusion® Ointment
Barrier Therapeutics
Approved for the treatment of diaper dermatitis complicated by candidiasis. US FDA
Fluocinonide 0.1% Cream
VANOS™
Medicis
Approval of additional indications for this Class I corticosteroid as primary therapy for all inflammatory and pruritic skin conditions, including eczema and poison ivy, in patients 12 years of age or older. Originally indicated for plaque-type psoriasis. US FDA
Immuno-
modulatory
Agents
Mycophenolate Mofetil
CellCept®
Aspreva/Roche
This immunosuppressive agent was granted orphan drug designation for the treatment of pemphigus vulgaris. US FDA
Medical Device Humira® Pen
Abbott Laboratories
This new device was approved for the administration of Humira®, a biologic treatment for moderate-to-severe rheumatoid arthritis and psoriatic arthritis. The device offers ease of use with its one-touch activation. US FDA
Oncologic Agents Multi-subtype, Natural Human Alpha Interferon
Multiferon®
Viragen International
Approved for the first-line adjuvant treatment of high-risk (Stages IIb-III) malignant melanoma following dacarbazine therapy (DTIC) after surgical removal of tumors. MPA Sweden
Oblimersen Sodium Injection
Genasense™
Genta
Orphan Drug designation was granted for the treatment of patients with Stage IV malignant melanoma. TGA Australia
Vorinostat Capsules
Zolinza™
Merck
The FDA approved this histone deacetylase inhibitor for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma who have progressive, persistent, or recurrent disease on or following two systemic therapies. US FDA
Rosacea Doxycycline Capsules
Oracea®
CollaGenex
Approval of doxycycline 40mg capsules for the treatment of inflammatory lesions (papules and pustules) of adult patients with rosacea. US FDA
Psoriatic Arthritis Agents Adalimumab
Humira®
Abbott
The FDA has approved an expanded indication for Humira® that includes inhibiting structural joint damage and improving physical function in patients with psoriatic arthritis. Previously approved indications include severe rheumatoid arthritis and active ankylosing spondylitis. US FDA
Infliximab
Remicade®
Schering-Plough
Revised indication to include the treatment of early rheumatoid arthritis and expanded new indication for psoriatic arthritis. TGA
Australia
Infliximab
Remicade®
Centocor
FDA has extended its approval of infliximab for inhibiting progression of structural damage and improving physical function in patients with psoriatic arthritis, in addition to reducing signs and symptoms of active arthritis. US FDA
US FDA Ketoconazole Gel 2%
Xolegel™
Barrier Therapeutics
Approved for the topical treatment of seborrheic dermatitis in immunocompromised adults and children 12 years of age and older. US FDA
Sunscreens Avobenzone 2%, Ecamsule 2% & Octocrylene 10% Cream
Anthelios SX®
L’Oréal/ La Roche Posay
This OTC SPF15 broad spectrum sunscreen was approved for photoprotection and the prevention of sunburn. US FDA