|Approval Dates and Comments
Tofacitinib citrate tablets
In November 2012, the US FDA approved tofacitinib citrate 5 mg twice daily for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have demonstrated an inadequate response or intolerance to methotrexate (MTX). Xeljanz® may be used as monotherapy or in combination with MTX or other non-biologic disease-modifying antirheumatic drugs (DMARDs). It should not be used in combination with biologic DMARDs or with potent immunosuppressives, such as azathioprine and cyclosporine. This approval represents the first approved RA treatment in a new class of drugs known as Janus kinase (JAK) inhibitors and the first new oral DMARD approved for RA in more than 10 years.
Lidocaine 7% + tetracaine 7% cream
The FDA approved a supplemental New Drug Application (sNDA) in October 2012 for 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 laserassisted tattoo removal. The product uses the manufacturer’s proprietary phase-changing technology to form a pliable peel on the skin when exposed to air. In clinical investigations, the most common local reactions included erythema (47%), skin discoloration (16%), and edema (14%). These reactions were generally mild and transient, resolving spontaneously soon after treatment. The most common systemic adverse events were headache, vomiting, dizziness and fever, all occurring with a frequency of <1%.
Calcipotriene 0.005% + betamethasone dipropionate 0.064% topical suspension
The FDA approved calcipotriene 0.005% + betamethasone dipropionate 0.064% topical suspension in October 2012 for the treatment of body plaque psoriasis. This formulation is a first-line single therapy that is indicated for both scalp and body plaque psoriasis for up to 8 weeks. It is the only once-daily, steroidcontaining topical treatment that combines both a vitamin D analog and a corticosteroid.
The FDA has expanded the approved indication for this first humanized interleukin-6 receptor-inhibiting monoclonal antibody in October 2012 to include the treatment of adults with moderately to severely active rheumatoid arthritis who have experienced an inadequate response to one or more DMARDs. Treatment is administered intravenously and can be used as monotherapy or in combination with MTX or other DMARDs.
C1 esterase inhibitor (human)
Health Canada has granted approval in October 2012 to this highly purified, pasteurized and nanofiltered plasma-derived C1 esterase inhibitor product indicated for routine prophylaxis against angioedema attacks in adolescent and adult patients with hereditary angioedema (HAE). Commercial availability in Canada is project for the second quarter of 2013.
Doxycycline monohydrate 40 mg capsules
Approved as the first and only oral anti-inflammatory for the treatment of inflammatory lesions (papules and pustules) of rosacea by Health Canada in November 2011, doxycycline monohydrate in a sub-antimicrobial, 40 mg modified release formulation (30 mg immediate + 10 mg delayed release) has recently undergone a name change from Efracea® to Apprilon® and is set for commercial launch in Canada in January 2013.