|Adapalene Gel 0.3%
|Approval granted for a higher concentration formulation of this topical retinoid for the treatment of moderate-to-moderately severe acne.
|Drospirenone/ Ethinyl Estradiol
|A new indication approved for the treatment of moderate acne vulgaris in women wanting an oral contraceptive for birth control.
|Tretinoin 0.05% Gel
|Approved this topical retinoid for the treatment of acne vulgaris.
|Daptomycin for Injection
|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.
|Retapamulin Ointment 1%
|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.
|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.
|Ciclopirox Topical Solution 8%
|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).
|Ketoconazole 2% Foam
|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.
|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.
Aerius®/ Azomyr®/ Neoclarityn®
|Two new formulations of this antihistamine were approved.
|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.
|Loratadine Dry Syrup 1%
|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.
|Nanocrystalline Silver Cream
|Approved for broad spectrum protection against microbes including strains resistant to MRSA, such as Pseudomonas aeruginosa and Staphylococcus aureus.
|Approved for the treatment of moderate-to-severe plaque psoriasis.
TEVA Pharmaceutical Industries
|Approval granted to the first generic formulation of famciclovir for the treatment of herpes zoster (shingles).
|Clobetasol Propionate 0.05%
|Approved for the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses (psoriasis and eczema) in patients =12 years of age.
|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.
|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.
|Hyaluronic Acid Gel Particles
|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.
|Hyaluronic Acid Injectable Soft Tissue Filler
Anika Therapeutics / Galderma
|Approved as a soft tissue filler for the treatment of facial wrinkles and scar remediation.
|Cross-Linked Hyaluronic Acid Injectable Gel
Juvéderm™ Ultra Plus
|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.
|Approved a lower-strength tablet formulation (lopinavir 100mg + ritonavir 25mg) for pediatric HIV patients weighing >15kg who are able to swallow the intact tablet.
|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.
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.
|Rose Bengal Disodium 10%
|Orphan Drug designation was granted to this anti-cancer drug for the treatment of metastatic melanoma.
|Cervical Cancer Vaccine
|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.
|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.
|Vaccinia Immune Globulin
|Approved for counteracting certain complications associated with smallpox vaccination.