|Approval Dates and Comments
Varicella zoster immune globulin (human) injection
The US FDA approved this varicella zoster immune globulin preparation in December 2012 for reducing the severity of varicella zoster virus (VZV) infections in high risk individuals when given within 4 days after exposure. VZV causes chickenpox in children and shingles in adults. Varizig® is made from plasma containing high levels of anti-varicella antibodies (immunoglobulin class G [IgG]) and is the only FDA approved immune globulin for VZV post-exposure prophylaxis treatment available in the US. It was designated as an orphan drug and received a priority review.
Lidocaine 7% + tetracaine 7% cream
Health Canada issued a Notice of Compliance (NOC) in December 2012 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 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. A pinprick test was used to evaluate the duration of effect in 40 adults. Study findings showed the median duration of analgesia was 11 hours. With respect to the mean for time to return of sensation, there was no difference between the 30-minute and 60-minute Pliaglis® application periods. However, at the end of the 13-hour study period 55% of treated subjects still reported diminished sensation. US FDA approval was granted in October 2012.
Health Canada approved a New Drug Submission (NDS) in November 2012 for this novel formulation of isotretinoin indicated to treat severe, recalcitrant, nodular acne in patients 12 years of age and older. Treatment is administered orally, once or twice daily, for approximately 5 months. Compared with other currently available isotretinoin products (including Accutane®, Hoffman-La Roche Ltd.), this new formulation provides more reliable absorption under varying dietary conditions. A significant challenge for existing isotretinoin products is patient compliance, as the active ingredient must be taken with a highfat meal to ensure consistent absorption. The rate and the extent of absorption of Epuris™ is equivalent to Accutane® under highfat, fed conditions, however, Epuris™ is 83% more bioavailable when taken without food. Product launch in Canada is expected during the second quarter of 2013. US FDA approval was granted in May 2012 under the trade name of Absorica™.
Laser hair therapy
iGrow® Hair Growth Platform
The FDA granted 510(k) marketing clearance in January 2013 to this red light technology device for the treatment of androgenetic alopecia (male pattern hair loss). This system treats affected areas of the scalp, requires no manual movement, and is the first hands-free low level laser therapy hair growth device cleared by the FDA for at-home use.
LED device for acne
The FDA granted marketing clearance in January 2013 to this biophotonic or light emitting diode (LED) device for six separate indications, including the treatment of acne, muscle and joint pain, muscle and joint stiffness, muscle spasm, arthritis and compromised local blood circulation.