| Type/Class of Therapy | Generic/Trade/ Company Names | Indication | Approving Regulatory Agency |
| Acne | Adapalene 0.1% + benzoyl peroxide 2.5% gel Epiduo® Galderma Laboratories |
This gel formulation of adapalene and benzoyl peroxide was approved for the topical treatment of acne vulgaris in patients ≥12 years of age. | US FDA |
| Adapalene 0.3% gel Differin® Galderma Laboratories |
A pump dispenser for this retinoid gel formulation was approved for the topical treatment of acne vulgaris in patients ≥12 years of age. | US FDA | |
| Tazarotene 0.1% foam Fabior™ Stiefel Laboratories |
A new retinoid formulation was approved for the topical treatment of acne vulgaris in patients ≥12 years of age. | US FDA | |
| CIP-Isotretinoin capsule Epuris™ (in Canada) Absorica™ (in US) Cipher Pharmaceuticals |
Approval was granted to this novel formulation of isotretinoin for the treatment of severe recalcitrant nodular acne. It offers a precise, consistent, and uniform dosage delivery with an absorption characteristic that is stable with or without food when compared with traditional generic isotretinoin. | Health Canada
US FDA |
|
| Actinic Keratosis | Ingenol mebutate gel (0.015%, 0.05%) Picato® Leo Pharma Inc. |
Ingenol mebutate gel (derived from the Euphorbia peplus plant) received approval for the topical treatment of actinic keratosis. The 0.015% formulation is used once-daily on the face and scalp for 3 consecutive days, and the 0.05% gel is used oncedaily on the trunk and extremities for 2 consecutive days. The treatment course may be completed in 2-3 days. | US FDA |
| Imiquimod 3.75% cream Zyclara® Meda AB |
Marketing authorization was granted to this immune response modifier for the topical treatment of actinic keratosis. Regulatory approval is valid in all European Union countries. | European Commission | |
| Anesthetic | Lidocaine 7% + tetracaine 7% cream Pliaglis® Nuvo Research Inc. Galderma Laboratories |
Approval was granted to this topical local anesthetic cream indicated for use on intact skin in adults to provide local analgesia for superficial aesthetic procedures, such as dermal filler injection, pulsed dye laser therapy, facial laser resurfacing, and laser-assisted tattoo removal. | Health Canada
US FDA |
| Brittle Nail Syndrome | Poly-ureaurethane 16% nail solution Nuvail™ Innocutis Medical |
This poly-ureaurethane 16% nail solution was approved for the management of fragile, damaged or brittle nails with cracking or splitting (referred to as nail dystrophy). It mechanically supports the damaged nail plate, forming a barrier that protects from further injury and strengthens the nail. | US FDA |
| Dermal Fillers and Injectables | Hyaluronic acid-based dermal filler Belotero® Balance Merz Aesthetics/Anteis SA |
This hyaluronic acid-based cohesive gel dermal filler was approved for the temporary correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. | US FDA |
| Hyaluronic acid injectable gel Restylane-L® Medicis Aesthetics |
Approval of an additional indication was granted to this transparent hyaluronic acid gel dermal filler to include submucosal implantation for lip augmentation in patients >21 years of age. | US FDA | |
| Dupuytren’s Contracture | Collagenase clostridium histolyticum Xiaflex® Actelion Pharmaceuticals 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. | Health Canada |
| Hereditary Angioedema | C1 esterase inhibitor (human) Cinryze® ViroPharma Incorporated |
This highly purified, pasteurized and nanofiltered plasmaderived C1 esterase inhibitor product was approved for routine prophylaxis against angioedema attacks in adolescent and adult patients with hereditary angioedema. | Health Canada |
| Herpes Zoster Virus (VZV) Infection | Varicella zoster immune globulin (human) injection Varizig® Cangene Corporation |
This varicella zoster immune globulin preparation was approved for reducing the severity of chicken pox infections in high risk individuals when given within 4 days after exposure. It is the only FDA approved immune globulin for VZV postexposure prophylaxis treatment available in the US. | US FDA |
| Lice | Ivermectin 0.5% lotion Sklice™ Sanofi Pasteur U.S. |
Approval was granted to this broad-spectrum antiparasitic agent for the topical treatment of head lice in patients ≥6 months of age. Most infestations are eradicted with a single 10-minute application and without nit combing. | US FDA |
| 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. | Health Canada |
| Vismodegib capsule Erivedge™ Genentech Roche Group Curis, Inc. |
Approval was granted to this hedgehog pathway inhibitor for the treatment of adults with advanced basal cell carcinoma (BCC). The drug is administered orally once-daily and is indicated for patients with locally advanced BCC who are not candidates for surgery or radiation and for patients with metastatic BCC. | 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 mutation-positive 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. | European Commission
Health Canada |
|
| Psoriasis | Calcipotriene 0.005% + betamethasone dipropionate 0.064% topical suspension Taclonex® LEO Pharma Inc. |
This topical suspension of a vitamin D analog with a corticosteroid was approved for the treatment of body plaque psoriasis. This formulation is a first-line single therapy that is indicated for once-daily treatment of both scalp and body plaque psoriasis for up to 8 weeks. | US FDA |
| Calcipotriene 0.005% foam Sorilux™ Stiefel, a GSK Company |
A supplemental New Drug Application (sNDA) was approved for calcipotriene foam 0.005%, expanding the sanctioned indications to include the topical treatment of plaque psoriasis of the scalp. With these recent changes, this topical synthetic vitamin D3 analog is now indicated for the treatment of plaque psoriasis of the scalp and body in patients >18 years of age. | US FDA | |
| Psoriatic Arthritis | Delayed-release prednisone tablets Rayos® Horizon Pharma, Inc. |
A delayed-release corticosteroid was approved as an antiinflammatory or immunosuppressive agent to treat a wide spectrum of diseases including rheumatoid arthritis, psoriatic arthritis, polymyalgia rheumatica, ankylosing spondylitis, asthma, and chronic obstructive pulmonary disease (COPD). | US FDA |
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