| Type/Class of Therapy | Generic/Trade/ Company Names | Indication | Approving Regulatory Agency |
| Acne | Adapalene 0.1% + benzoyl peroxide 2.5% gel Tactuo™ Galderma Canada Inc. | This novel once-daily retinoid and benzoyl peroxide combination gel was approved for treating mild to moderate acne vulgaris in patients ≥12 years of age. The product is marketed in the US under the trade name of Epiduo®, which was FDA approved in 2008. | Health Canada |
| Actinic Keratosis | 5-fluorouracil cream 0.5% + salicylic acid 10% Actikerall® Almirall, S.A. | Marketing approval was granted to this topical combination solution for treating palpable and/or moderately thick hyperkeratotic actinic keratosis (grade I/II) in adults. | MHRA (UK) |
| Dermal Fillers and Injectables | Autologous cell therapy dermal filler laVív® (azficel-T) Fibrocell Science, Inc. | This first novel personalized aesthetic cell therapy was approved for improving the appearance of moderate to severe nasolabial folds in adults. The technological platform used to create this product is a patented process that extracts, isolates, and multiplies a person’s own skin cells (collagen producing fibroblasts), which are then injected into their wrinkles. | US FDA |
| Hyaluronic acid dermal filler Belotero® Balance Merz Aesthetics Anteis SA | Approval was granted for the temporary correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. This hyaluronic acid-based monophasic gel dermal filler utilizes cohesive polydensified matrix technology to increase the product’s elasticity and viscosity. | US FDA | |
| Hyaluronic acid dermal filler Restylane® Medicis Aesthetics | An additional indication was granted to this injectable gel for lip augmentation. Restylane® was previously approved to treat moderate to severe facial wrinkles and folds, such as nasolabial folds. The new label will now include an indication for submucosal implantation for lip augmentation in patients >21 years of age. | US FDA | |
| IncobotulinumtoxinA injection XEOMIN® Merz Aesthetics | Approval was granted to this injectable botulinum toxin type A product for the temporary improvement in the appearance of moderate to severe glabellar lines in adult patients. | US FDA | |
| Dermatoses | Oxychlorine compound Epicyn™ HydroGel Oculus Innovative Sciences | A new skin care gel was approved as a medical device for the management of burning, itching, and pain associated with various types of dermatoses, including atopic dermatitis and radiation dermatitis. This prescription product is intended for use under the supervision of a healthcare professional. In addition, the gel relieves the pain of first- and second-degree burns and maintains a moist wound and skin environment to help treat dry and waxy skin. | US FDA |
| Dupuytren’s Contracture | Collagenase clostridium histolyticum XIAPEX® Pfizer Inc. BioSpecifics Technologies Auxilium Pharmaceuticals | Approval was granted to this novel, first-in-class biologic for the treatment of Dupuytren’s contracture in adults with a palpable cord. The injected enzymes dissolve and weaken the contracted collagen cord. It is the only nonsurgical option for Dupuytren’s disease. US FDA approval was gained in 2010 under the tradename XIAFLEX® | EC/EMA (European Union) |
| Genital Warts | Imiquimod 3.75% cream Vyloma™ / Zyclara® Graceway Pharmaceuticals (acquired by Medicis Pharmaceutical Corp.) | This immune response modifier was approved for the topical treatment of external genital warts and perianal warts. Studies demonstrated that the once-daily treatment regimen for up to 8 weeks was safe and provided sustained efficacy. | Health Canada US FDA |
| Hereditary Angioedema | Icatibant injection Firazyr® Shire Human Genetic Therapies | Approval was granted to this selective B2 bradykinin receptor antagonist for the treatment of acute attacks of hereditary angioedema (HAE) in adults ≥18 years of age. Upon recognition of an HAE attack, patients may self-administer through an injection in the abdominal area. In three clinical trials, the reported median time for onset of symptom relief was 2 hours vs. 20 hours with placebo. | US FDA |
| Lice | Spinosad 0.9% cream rinse Natroba™ ParaPRO, LLC | A topical suspension of spinosad was approved for the treatment of head lice in patients ≥4 years of age. Spinosad is a compound derived from a soil microbe and its mechanism of action includes excitation of neurons in the central nervous system, then hyperexcitation, and paralysis, leading to death of the insect. This prescription product resolves most head lice infestations in about 10 minutes with one application, and nit combing is not required. | US FDA |
| Dimethicone topical solution NYDA® G. Pohl-Boskamp GmbH Pediapharm Inc. | This new OTC pesticide-free pediculicide was approved for the physical treatment of head lice infestation. The active ingredient, dimethicone, works by suffocating the lice, nymphs, and eggs. Due to its physical mode of action (interruption of the lice’s oxygen supply of the central nervous system) development of resistance appears unlikely | Health Canada | |
| Melanoma | Ipilimumab Yervoy™ Bristol-Myers Squibb | This human monoclonal antibody was approved for the treatment of metastatic melanoma. Administered intravenously, the drug blocks a T-lymphocyte antigen (CTLA-4), altering the body’s ability to fight off cancerous cells and allowing the immune system to recognize, target, and attack cells in melanoma tumors. Due to the potential for unusual and severe side-effects, approval is accompanied by a FDA-mandated Risk Evaluation and Mitigation Strategy (REMS) to inform health care professionals about these serious risks. | EC/EMA (European Union) US FDA |
| Peginterferon alfa-2b Sylatron™ Merck & Co Inc. Schering Corporation | This adjuvant therapy was approved to treat node-positive melanoma after surgical resection. Therapy is administered subcutaneously (may be self-injected) and is indicated as an adjuvant treatment of melanoma with microscopic or gross nodal involvement within 84 days of definitive surgical resection. A clinical study showed that patients who received the drug delayed cancer recurrence by approximately 9 additional months. One-third of peginterferon alfa-2b-treated patients ceased therapy due to adverse effects. | US FDA | |
| Vemurafenib tablets Zelboraf™ Genentech/Roche Group Plexxikon/Daiichi Sankyo Group | Approval was granted to this oral, small molecule, kinase inhibitor for the treatment of metastatic or unresectable melanoma. Therapy is specifically indicated for patients with BRAFV600E mutationpositive melanoma. This BRAF enzyme inhibitor was approved with a companion diagnostic called the cobas® 4800 BRAF V600 Mutation Test, which determines a patient’s eligibility for treatment. Common reported side-effects of vemurafenib include joint pain, rash, hair loss, tiredness, sunburn or sun sensitivity, nausea, itching, or warts. | US FDA | |
| Post-herpetic Neuralgia | Gabapentin tablets GRALISE™ Depomed, Inc. Abbott Products, Inc. | A new formulation of gabapentin extended release tablets was approved for the once-daily treatment of post-herpetic neuralgia, the pain following herpes zoster infection (shingles). This preparation is not interchangeable with other gabapentin products because of differing pharmacokinetic profiles that affect the frequency of administration. The FDA has granted GRALISE™ Orphan Drug status. | US FDA |
| Systemic Lupus Erythematosus | Belimumab Benlysta® Human Genome Sciences GlaxoSmithKline | This new first-in-class human monoclonal antibody was approved for the treatment of systemic lupus erythematosus (SLE). Treatment is indicated for adult patients with active, autoantibodypositive SLE who are receiving standard therapy. The drug inhibits the biological activity of the B-lymphocyte protein (BLyS). Elevated levels of BLyS are associated with autoimmune disorders and are believed to contribute to the production of autoantibodies that attack and destroy the body’s own healthy tissues. It is the first new lupus drug to receive regulatory approval in more than 50 years. | EC/EMA (European Union) Health Canada US FDA |
