| Drug Class | Generic/Trade Company Names | Indication | Approving Regulatory Agency |
Actinic Keratosis | Imiquimod Cream 3.75% Graceway Pharmaceuticals | This immune response modifier was approved for the topical treatment of multiple actinic keratoeses located on the face or balding scalp in adults. | Health Canada |
Antibacterial | Telavancin Theravance Inc./Astellas Pharma | Approved as a once daily injectable antibiotic for the treatment of adults with complicated skin and skin structure infections caused by susceptible Gram-positive bacteria, including Staphylococcus aureus, both methicillin-resistant and methicillin-susceptible strains. | Health Canada; |
Anticancer | Photopheresis System Johnson & Johnson | Approved for the palliative treatment of skin manifestations of cutaneous T-cell lymphoma (CTCL) unresponsive to other forms of treatment. | Health Canada |
Romidepsin Gloucester Pharmaceuticals | This histone deacetylase inhibitor was approved for the treatment of CTCL in patients who have received at least 1 prior systemic therapy. | US FDA | |
Antihistamine | Levocetirizine Dihydrochloride UCB/sanofi-aventis | Approved for the relief of symptoms from perennial allergic rhinitis and chronic idiopathic urticaria in children =6 months of age. | US FDA |
Antipsoriatic | Calcitriol Ointment Galderma Laboratories | Approval was granted to this novel topical vitamin D3 agent for the treatment of mild-to-moderate plaque psoriasis in adults. | US FDA |
Etanercept Wyeth | A new indication was granted to this biologic for the treatment of chronic severe plaque psoriasis in children aged =8 years. | EMEA | |
Ustekinumab Centocor Ortho Biotech/ | This first-in-class human monoclonal antibody that selectively targets the cytokines interleukin-12 and interleukin-23 was approved for the treatment of moderate-to-severe plaque psoriasis in adults =18 years of age. | EMEA; | |
Antiviral | Acyclovir + Hydrocortisone Cream Medivir AB | This topical product combining an antiviral with an anti-inflammatory was approved for the prevention and treatment of recurrent herpes labialis. Indicated for adults and children =12 years of age. | EMEA; |
Dermal Fillers | AbobotulinumtoxinA Medicis/Ipsen | Approval of this acetylcholine release inhibitor and neuromuscular blocking agent was granted for the temporary improvement in the appearance of moderate-to-severe glabellar lines in adults aged | US FDA |
Botulinum Toxin – Type A Galderma/Ipsen | This neurotoxin received approval for the temporary improvement in the appearance of moderate-to-severe glabellar lines in adult patients | Agence Française de Sécurité Sanitaire de Produits de Santé (France) | |
Collagen-based Dermal Filler Ortho Dermatologics | A labeling supplement was approved, that includes efficacy and safety data through 12 months, for this collagen-based dermal filler for the correction of moderate to deep facial wrinkles and folds. | US FDA | |
Injectable Poly-L-lactic Acid sanofi-aventis US | Approved for the correction of shallow to deep nasolabial fold contour deficiencies and other facial wrinkles. | US FDA | |
Hand Eczema | Alitretinion Basilea Pharmaceutica | Approved as a once daily oral retinoid treatment for adults with severe chronic hand eczema refractory to potent topical corticosteroids. | Health Canada; |
HIV/AIDS | Darunavir Tibotec/Janssen-Ortho | This antiretroviral agent was approved for the treatment of HIV infection to be used once daily in treatment-naïve adults in combination with other antiretroviral agents, such as ritonavir. | Health Canada |
Etravirine Tablets Tibotec Therapeutics | Approved for use in treatment-experienced adults who are encountering virologic failure with HIV-1 strains resistant to a non-nucleoside reverse transcriptase inhibitor and other antiretroviral agents. | US FDA | |
Lice | Benzyl Alcohol Lotion 5% Sciele Pharma | This new prescription non-neurotoxic medication was approved for the treatment of head lice in patients =6 months of age. | US FDA |
Postherpetic Neuralgia | Capsaicin 8% Transdermal Patch NeurogesX, Inc. | Approved for the management of neuropathic pain due to postherpetic neuralgia. This medicated skin patch can provide up to 12 weeks of pain reduction following a single 1-hour application. | EMEA; |
Psoriatic Arthritis | Golimumab Centocor Ortho Biotech/ | This once monthly, subcutaneous, anti-TNF-a human monoclonal antibody was approved for the treatment of moderate-to-severe rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. | EMEA; |
Vaccines | Human Papillomavirus Bivalent GlaxoSmithKline | Approved for the prevention of cervical pre-cancers and cervical cancer associated with oncogenic human papillomavirus (HPV) types 16 and 18; for use in girls and women aged 10-25 years. | US FDA |
Human Papillomavirus Quadrivalent Merck & Co. | Approved for use in boys and men 9-26 years of age for the prevention of genital warts caused by HPV types 6 and 11. | US FDA | |
Wound Care | Small Molecule Oculus Innovative Sciences | Clearance was given to market this product (both as a prescription and an OTC formulation) for the management of exuding wounds (e.g., leg ulcers, pressure ulcers, and diabetic ulcers) and for the management of mechanically or surgically debrided wounds. | US FDA |
Other | Estradiol Vaginal Tablet Novo Nordisk | Approved for the treatment of atrophic vaginitis due to menopause. | US FDA |
