Name/CompanyApproval Dates and Comments

Acyclovir 50 mg buccal tablets

BioAlliance Pharma

The US FDA approved acyclovir buccal tablets in April 2013 for the treatment of recurring herpes labialis (cold sores). This novel formulation is available as a mucoadhesive tablet that is self-administered by placement on the gum, delivering a high concentration of acyclovir directly to the site of the cold sore infection. A Phase 3 international study of 775 patients showed that in addition to its efficacy, this treatment was unobtrusive and offered simplified dosing with a single application for the entire duration of an episode of herpes labialis. Sitavig® should be applied within 1 hour after experiencing prodromal symptoms (e.g., itching, redness, burning, or tingling, and before a cold sore appears). The buccal tablet should be applied to the upper gum, just above the incisor tooth on the same side of the mouth as the cold sore symptoms.

Acyclovir 5% + hydrocortisone 1% cream

Valeant Canada

Health Canada issued a Notice of Compliance (NOC) in March 2013 for this topical combination therapy indicated for the early treatment of recurrent herpes labialis to reduce the likelihood of ulcerative cold sores and to shorten the lesion healing time in adults and adolescents (≥12 years of age). Xerese® contains acyclovir, a synthetic nucleoside analogue active against herpes viruses, and hydrocortisone, an anti-inflammatory corticosteroid.

Botulinum toxin type A for injection


Health Canada granted a marketing authorization in April 2013 for abobotulinumtoxinA (Dysport®) for the temporary improvement in the appearance of moderate to severe glabellar
lines (frown lines) in adults <65 years of age. The active agent is a botulinum neurotoxin type A complex that acts at the level of the neuromuscular junction in the targeted muscle to block acetylcholine secretion, which reduces muscular spasm.

Desoximetasone 0.25% topical spray

Taro Pharmaceutical

The US FDA approved a New Drug Application (NDA) for this topical corticosteroid spray in April 2013, which is indicated for the treatment of plaque psoriasis in patients ≥18 years of age.

Carbinoxamine maleate extendedrelease oral suspension

Karbinal™ ER
Tris Pharma

In April 2013, the FDA approved carbinoxamine maleate
extended-release oral suspension 4 mg/5 ml, the first sustainedrelease histamine receptor blocking agent indicated for the treatment of seasonal and perennial allergic rhinitis in children ages ≥2 years of age. Sanctioned uses include the symptomatic treatment of seasonal and perennial allergic rhinitis; vasomotor rhinitis; allergic conjunctivitis due to inhalant allergens and foods; mild, uncomplicated allergic skin manifestations of urticaria and angioedema; and dermatographism. Carbinoxamine, an H1 receptor antagonist, is a mildly-sedating antihistamine and may be a therapeutic option for allergy sufferers who are unresponsive to second-generation antihistamines or dissatisfied with dosing schedules associated with first-generation antihistamines.

C1-esterase inhibitor

CSL Behring

Health authorities in 23 European countries have approved an extended use of this C1-esterase inhibitor (C1-INH) concentrate in April 2013 for pre-procedure prevention (short-term prophylaxis) of acute episodes of hereditary angioedema (HAE) in adult and pediatric patients undergoing medical, dental or surgical procedures. In addition to short-term prophylaxis, Berinert® is indicated in Europe for the treatment of acute attacks of HAE at all body sites in adults and children. The therapy is self-administred by intravenous infusion for eligible and trained patients.