Teva Announces Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol) Tablets Now Available for the Prevention of Pregnancy in the United States
NORTH WALES, Pa., Sept. 24, 2013 -- Teva Women's Health, a U.S. subsidiary of Teva Pharmaceutical Industries Ltd., today announced that the recently approved Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol) tablets are now available via prescription in the U.S. for the prevention of pregnancy. Quartette represents the only extended-regimen oral contraceptive approved by the U.S. Food and Drug Administration (FDA) with an ascending dose of estrogen designed to provide women with four short, light periods per year.
There is no medical need for a woman to have a monthly period when she is on an oral contraceptive. Quartette extends a woman's cycle from a typical 28 days to 91 days, allowing only 4 periods per year and therefore 9 months out of the year without a period. Women who take Quartette will likely have more bleeding or spotting between scheduled periods compared to taking a birth control pill with a 28-day dosing cycle. This bleeding or spotting tends to decrease with each additional cycle.
"New contraceptive options, such as Quartette, can help women to manage their reproductive and contraceptive health in a way that fits their individual needs," said David Portman, M.D., Columbus Center for Women's Health Research, Columbus, Ohio and clinical investigator of Quartette. "Quartette's dosing regimen makes it an option for women who want to have more period-free days, with four scheduled periods per year."
Teva is offering a Quartette Savings Card as part of the company's dedication to providing affordable birth control to women. Certain terms and restrictions apply. Visit HerQuartette.com for more information.
"Teva Women's Health has led the pharmaceutical industry in the development and marketing of extended-regimen oral contraceptives of which Quartette is the most recent option," said Martin Berndt, Vice President & General Manager, U.S. Brand Pharmaceuticals, Teva Women's Health, Inc. "Through striving to address unmet needs and closely engaging with women and healthcare providers, Teva continues to serve as a true partner for women as they manage their health through their reproductive years."
About Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol) Tablets
Quartette is the first extended-regimen oral contraceptive where the dose of estrogen gradually increases at three distinct points for the first 84 days and was approved by the U.S. Food and Drug Administration (FDA) on March 29, 2013 for the prevention of pregnancy. The efficacy and safety of Quartette was evaluated in a Phase III multicenter, open-label, single arm study of more than 3,000 sexually active women at risk for pregnancy between the ages of 18-35. Quartette was 97 percent effective at preventing pregnancy.
Data further demonstrated that the most common adverse reactions (?2%) were headaches, heavy/irregular vaginal bleeding, nausea/vomiting, acne, dysmenorrhea, increased weight, mood changes, anxiety/panic attack, breast pain and migraines. The primary clinical trial that evaluated the efficacy of Quartette also assessed breakthrough bleeding (BTB). BTB and unscheduled spotting decreased over successive 91 day cycles. Quartette reduced the mean number of days with breakthrough bleeding (BTB) by half from cycle 1 to cycle 2 and spotting was cut in half from cycle 1 to cycle 3.i