| 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.
| 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 |
