Name/CompanyApproval Dates and Comments


Cipher Pharmaceuticals

The US FDA has approved this novel formulation of isotretinoin in May 2012 for the treatment of severe recalcitrant nodular acne. According to the manufacturer, CIP-isotretinoin is based on the patented oral Lidose® drug delivery system, which offers precise, consistent, and uniform dosage delivery with an absorption characteristic that is stable with or without food when compared with traditional generic isotretinoin. A major challenge for existing isotretinoin products is patient adherence, as the active ingredient should be taken with a high-fat meal to ensure consistent absorption. Currently available generic isotretinoin products have an estimated 65% variability in absorption depending on dietary intake, resulting in inconsistent dosing and pharmacokinetic implications, which is of particular concern in teenaged patients. Hence, CIP-istotretinoin was designed to maintain steady drug absorption throughout the typical 3- to 5-month course of treatment. Product launch in the US is expected in Q4 2012 and it is currently under Health Canada review

Tazarotene 0.1% foam

Stiefel Laboratories

FDA approval was granted to a novel retinoid formulation in May 2012 for the topical treatment of acne vulgaris. Therapy is indicated for acne patients ≥12 years of age. The approval of tazarotene foam was based on two multicenter, randomized, double-blind, vehicle-controlled pivotal Phase 3 studies. The most common side-effects were application site reactions, such as irritation, dryness, erythema, and exfoliation.

Butoconazole nitrate 2% vaginal cream

Perrigo Company

The FDA approved an abbreviated new drug application for this antifungal agent in May 2012, which is indicated for the local treatment of vulvovaginal candidiasis (infections cause by Candida). It is the generic equivalent of innovator brand Gynazole-1® (KV Pharmaceuticals).

Device News

Multisource radiofrequency aesthetic device

Glow by EndyMed™
EndyMed Medical Ltd
Eclipse Aesthetics

The FDA cleared this aesthetic device in May 2012 for the reduction of mild to moderate facial wrinkles and fractional radiofrequency (RF) skin resurfacing. Two versions are available: one with a non-ablative multisource RF dermal heating handpiece and the other with a multisource fractional RF skin resurfacing (FSR) handpiece. This system utilizes 3DEEP™ technology, a multisource, phase-controlled RF energy source and advanced software to control the phase of the energy flowing between the handpiece electrodes.

Low-level laser for circumferential upper arm reduction

Erchonia Medical

The FDA granted 510(k) clearance to market this bodycontouring laser treatment in June 2012 for the non-invasive reduction of arm circumference by emitting low-level (or cold) output energy that does not generate a thermal effect on body tissues. The device is a monochromactic semiconductor diode laser that emits 5 independent 635 nm divergent beams. A blinded and controlled clinical study showed that Zerona® laser demonstrated a statistically significant difference in circumference reduction, which was sustained 7.6 months post-treatment, as compared with a placebo laser. Subjects who received Zerona® laser therapy experienced approximately 4 cm reduction in the circumference of their arms without dieting, exercising or nutritional supplementation.