| 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 |
