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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 /PRNewswire/ -- 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) TabletsQuartette™ 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 

Indication Quartette™ (levonorgestrel/ethinyl estradiol and ethinyl estradiol) tablets are indicated for use by women to prevent pregnancy.

IMPORTANT SAFETY INFORMATION

Who should not take Quartette ?

WARNING TO WOMEN WHO SMOKEDo not use Quartette if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects from birth control pills, including death from heart attack, blood clots, or stroke. The risk increases with age and the number of cigarettes you smoke.

Do not take Quartette if you have or have had blood clots, liver disease or liver tumors, breast cancer or any cancer that is sensitive to female hormones, a history of heart attack or stroke, any unexplained bleeding from the vagina, or if you may be pregnant.

What are the most serious risks of taking Quartette™? Quartette™ increases the risk of serious blood clots, especially in women who have other risk factors, such as smoking, obesity, or age greater than 35. This increased risk is highest when you first start taking birth control pills and when you restart the same or different birth control pills after not using them for a month or more.

Call your healthcare provider right away if you have: persistent leg pain; sudden shortness of breath; sudden blindness (partial or complete); severe pain or pressure in your chest; sudden, severe headache unlike your usual headaches; weakness or numbness in an arm or leg, or trouble speaking; yellowing of the skin or eyeballs.

Depression can occur when taking Quartette™, especially if you have had depression in the past. Call your healthcare provider immediately if you have any thoughts of harming yourself.

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