|Approval Dates and Comments
Human papillomavirus (HPV) test
Cobas® HPV Test
The US FDA approved the cobas HPV test in April 2011 for identifying women at highest risk for developing cervical cancer. It individually identifies genotypes 16 and 18 (the two highest-risk HPV genotypes responsible for >70% of cervical cancer cases), as well as detects 12 other high risk HPV genotypes.
Health Canada approved a prescription only, foam formulation of betamethasone valerate, a midpotency corticosteroid, in May 2011 for the treatment of the inflammatory and pruritic manifestations of corticosteroid-responsive scalp dermatoses.
|Generic Drug Update
On June 14, 2011, the US FDA announced changes to sunscreen labeling that would
The US FDA1 and Health Canada2 issued separate advisories in May and June 2011, respectively, announcing that they are conducting safety reviews of drospirenonecontaining oral contraceptive pills (OCPs) to evaluate their potential for increased risk of venous thromboembolism in women who use these products. Blood clots are a rare but well known side-effect associated with all OCPs. The affected product brands are Yaz® and Yasmin® in Canada, and in the US they include Yaz® (generics Gianvi™ and Loryna™), Yasmin® (generics Ocella™, Syeda™, and Zarah™), Beyaz™, and Safyral™.
In May 2011, the European Medicines Agency (EMA)3 announced that it is updating the product information on OCPs containing drospirenone and ethinyl estradiol (Yasmin®, Yasminelle®, and other products) with respect to the risk of venous thromboembolism.
Two new studies recently published in the British Medical Journal4,5 suggest the risk of blood clots with drospirenone-containing OCPs may be two to three times greater than with OCPs containing the progestin levonorgestrel.