| Drug Class | Generic/Trade/ Company Names |
Indication | Approving Regulatory Agency |
| Acne | Adapalene 0.1% lotion Differin® Galderma Laboratories |
A novel lotion formulation of the retinoid adapalene was approved for the treatment of acne vulgaris in patients =12 years of age. This new formulation has been designed to improve tolerable efficacy and spreads easily. It is available in an easy-to-use pump dispenser and is indicated for application on the face and other areas of the body affected by acne. |
US FDA |
| Clindamycin phosphate 1.2% + tretinoin 0.025% gel Veltin™ Stiefel Laboratories, Inc./GSK |
This topical combination of an antibiotic with a retinoid in an aqueous gel vehicle was approved for the treatment of acne vulgaris in patients =12 years of age. |
US FDA | |
| Drospirenone / ethinyl estradiol / levomefolate calcium + levomefolate calcium tablets Beyaz™ Bayer HealthCare Pharmaceuticals Inc. |
Approval was granted to a new oral contraceptive (OC) to raise folate levels in women who choose an OC for birth control. The addition of levomefolate calcium raises folate levels for the purpose of reducing the risk of a neural tube defect in a pregnancy conceived while taking Beyaz™ or shortly after discontinuation. The approval of Beyaz™ is based on Yaz®, which contains the same doses of estrogen and progestin, and is approved for three indications: prevention of pregnancy; treatment of symptoms of premenstrual dysphoric disorder in women who choose an OC for contraception; and treatment of moderate acne vulgaris in women =14 years of age, but only if the patient prefers an OC for birth control. |
US FDA | |
| Actinic Keratoses |
Imiquimod cream 3.75% Zyclara™ Graceway Pharmaceuticals |
A new formulation of this immune response modifier was approved for the treatment of clinically typical, visible, or palpable actinic keratoses. It offers a convenient 6-week dosing cycle and is indicated for application over larger areas of skin (as compared with imiquimod 5%), including the full face and balding scalp in adults. |
Health Canada US FDA |
| Antibacterial Agents |
Ceftaroline fosamil Teflaro™ Forest Laboratories, Inc. |
This novel broad-spectrum injectable cephalosporin antibiotic was approved for the treatment of community acquired bacterial pneumonia and complicated skin and skin structure infections. Ceftaroline has activity against both gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA) and Streptococcus pneumoniae, and common gram-negative pathogens. |
US FDA |
| Daptomycin for injection Cubicin® Cubist Pharmaceuticals, Inc. |
This antibiotic received an additional indication as the only approved 2-minute IV injection for the treatment of MRSA-complicated skin infections and bacteremia. |
US FDA | |
| Cancer | CD56-binding monoclonal antibody (huN901) + maytansinoid cytotoxic agent (DM1) IMGN901 ImmunoGen, Inc. |
Orphan drug designation was granted to the IMGN901 compound (an antibody-drug conjugate) for the treatment of Merkel cell carcinoma. IMGN901 binds with high affinity to CD56 expressed on the surface of tumor cells. Once bound, the conjugate is internalized and the antimitotic agent (DM1) is released. |
European Medicines Agency (EMA) US FDA |
| Dermal Fillers and Injectables |
Hyaluronic acid dermal filler + 0.3% lidocaine JUVÉDERM®XC Allergan, Inc. |
A new formulation of this hyaluronic acid dermal filler was approved for the reduction of pain during treatment of moderate to severe facial wrinkles and folds (i.e., nasolabial folds). The addition of 0.3% preservative-free lidocaine my also shorten the treatment time by eliminating the need for an additional anesthetic. |
US FDA |
| Hyaluronic acid dermal filler + 0.3% lidocaine RESTYLANE®-L PERLANE®-L Medicis Aesthetics |
Additional formulations of these dermal fillers were approved for the reduction of pain associated with the injectable correction of moderate to severe nasolabial folds. These products provide patients with the option of a single syringe containing a wrinkle filler with a local anesthetic. RESTYLANE®-L is approved for injection into the mid to deep dermis and PERLANE®-L is approved for implantation into the deep dermis to superficial subcutis. |
US FDA | |
| Lysosomal Storage Diseases |
Agalsidase alfa REPLAGAL® Shire plc |
Fast Track designation was granted to this human-cell-line-derived enzyme replacement therapy for the long-term treatment of Fabry disease. Therapy is administered every other week by intravenous infusion. |
US FDA |
| Velaglucerase alfa VPRIV™ Shire plc |
Approval was granted to this hydrolytic lysosomal glucocerebrosidespecific enzyme for long-term enzyme replacement therapy in pediatric and adult patients with Type 1 Gaucher disease. Therapy is administered every other week by intravenous infusion. |
European Medicines Agency (EMA) US FDA |
|
| Psoriasis | Adalimumab Humira® Abbott Japan Co./Eisai Co. |
This fully-human monoclonal anti-TNF- antibody was approved for the additional indications of plaque psoriasis and psoriatic arthritis. |
MHLW (Japan) |
| Calcipotriene/Calcipotriol 0.005% foam Sorilux™ Stiefel, a GSK Company |
A novel foam formulation of calcipotriene 0.005% was approved for the topical treatment of mild to moderate plaque psoriasis in patients =18 years of age. Calcipotriene has been formulated using the VersaFoam® vehicle, a proprietary delivery technology. |
US FDA | |
| Calcitriol ointment Silkis™ Galderma Canada |
Approval was granted to this topical vitamin D3 agent for the treatment of mild-to-moderate plaque psoriasis in adults. This product was US FDA approved in 2009 under the trade name of Vectical™ |
Health Canada | |
| Psoriatic Arthritis |
Adalimumab Humira® Eisai Co., Ltd. |
This fully-human monoclonal anti-TNF- antibody was approved for the additional indications of plaque psoriasis and psoriatic arthritis. |
MHLW (Japan) |
| Vaccines | Human papillomavirus quadrivalent (Types 6, 11, 16, and 18) recombinant vaccine Gardasil® Merck & Co., Inc. |
An additional indication was granted to this human papillomavirus (HPV) vaccine for the prevention of infection caused by HPV types 6, 11, 16 and 18 and genital warts caused by HPV types 6 and 11 in boys and men 9-26 years of age. |
Health Canada |
| This HPV recombinant vaccine received an additional approved indication for the prevention of anal cancer caused by HPV types 16 and 18 and for the prevention of anal intraepithelial neoplasia (AIN) grades 1, 2 and 3 (anal dysplasias and precancerous lesions) caused by HPV types 6, 11, 16 and 18, in males and females 9-26 years of age. |
US FDA | ||
| Wound Care | Small molecule oxychlorine compound Microcyn® Skin and Wound HydroGel Oculus Innovative Sciences |
New dermatology indications were granted to Microcyn® Skin and Wound HydroGel. This prescription product is intended for use, under the supervision of a healthcare professional, in the management of wounds, including itch and pain relief associated with skin irritation, sores, injuries, and ulcers of dermal tissue. |
US FDA |
| Other | Collagenase clostridium histolyticum XIAFLEX™ Auxilium Pharmaceuticals |
This novel first-in-class, orphan-designated biologic was approved for the treatment of Dupuytren’s contracture in adults with a palpable cord. The injected enzymes dissolve and weaken the contracted collagen cord. This new treatment represents the only nonsurgical option for Dupuytren’s disease. |
US FDA |
| Polidocanol injection Asclera® BioForm Medical Inc./ Chemische Fabrik Kreussler & Co. |
Regulatory approval was granted to this sclerotherapy agent to improve the appearance of varicose veins. The injection treatment is used to close spider veins ( veins (1-3 millimeters in diameter). The agent acts by damaging the cell lining of blood vessels, causing the vessels to close, and leading to subsequent replacement by other types of tissue. |
US FDA |
