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
Nuvo Research Inc. Galderma Laboratories
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
LEO Pharma Inc.
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.
Genentech, Inc. Roche Group
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
Galderma Canada Inc.
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.