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Skin Treatments Introduced in 2012

Type/Class of Therapy Generic/Trade/
Company Names
Indication Approving Regulatory Agency
Acne 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
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
Dupuytren's Contracture Collagenase clostridium histolyticum
Xiaflex®
Actelion Pharmaceuticals
Auxilium Pharmaceuticals
Approval was granted to this novel, first-inclass 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 plasma-derived C1 esterase inhibitor product was approved for routine prophylaxis against angioedema attacks in adolescent and adult patients with hereditary angioedema. 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. Health Canada
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. European Commission
Health Canada

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