EMA/CHMP positive opinion for Teva’s Seasonique contraceptive

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion in a referral procedure regarding the authorization of Israel-based generics giant Teva Pharmaceutical Industries (NYSE: TEVA) extended-regimen oral contraceptive, Seasonique (levonorgestrel (0.15mg)/ethinyl estradiol (0.03mg) and low-dose ethinyl estradiol (0.01mg) tablets) for the prevention of pregnancy.

The CHMP concluded that the benefits of the product outweigh its risks clearing the way for Seasonique’s approval by local health authorities of the European Union member states and launch in select countries throughout Europe by the end of 2014, the company noted.

“Seasonique’s approval will allow physicians to prescribe their patients an oral contraceptive that offers less frequent menses and is both safe and effective," noted Rossella Nappi, Associate Professor of Obstetrics and Gynecology, IRCCS Policlinico San Matteo, University of Pavia, Italy, and investigator in the SeasoniqueEU study. “Women now starting on oral hormonal contraceptive will be able to choose to have a monthly menstrual period or not,” he noted.