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) 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
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 SMOKE
Do 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.
The most common side effects of Quartette™ in clinical trials were: headaches, heavy/irregular vaginal bleeding, nausea/vomiting, acne, pain with bleeding, weight gain, mood changes, anxiety/panic attack, breast pain, and migraine. This is not a complete list of possible side effects. Talk to your healthcare provider if you develop any side effects that concern you.
Tell your healthcare provider about all medicines and herbal products you take including daily long-term treatment for chronic conditions such as seizures or thyroid disease.
The pill does not protect against HIV infection (AIDS) and other sexually transmitted infections.
When you take Quartette™, which has a 91-day extended dosing cycle, you should expect to have 4 scheduled periods per year. Each period is likely to last about 3-4 days. However, you will probably have more bleeding or spotting between your scheduled periods than if you were using a birth control pill with a 28-day dosing cycle. This bleeding or spotting tends to decrease with each additional cycle.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please click here to see the full prescribing information, including Boxed Warning.
About Teva Women's Health, Inc.
Teva Women's Health, Inc. is a U.S.-based subsidiary of Teva Pharmaceutical Industries Ltd. (NYSE: TEVA), headquartered in Israel. The company produces a wide range of women's healthcare products including oral contraceptives, intrauterine contraception and hormone therapy treatments for menopause and perimenopause. Teva Women's Health, Inc. maintains a strong commitment to enhancing women's lives by actively pursuing new areas of research and providing distinct pharmaceutical options that meet women's needs and fit their lifestyles. Through close engagement with women and healthcare providers, the company maintains an in-depth understanding of the important health matters that affect women.
Teva's Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995:
This release contains forward-looking statements, which express the current beliefs and expectations of management. Such statements are based on management's current beliefs and expectations and involve a number of known and unknown risks and uncertainties that could cause our future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to: our ability to develop and commercialize additional pharmaceutical products, including our ability to develop, manufacture, market and sell biopharmaceutical products, competition for our innovative products, especially COPAXONE® (including competition from innovative orally-administered alternatives, as well as from potential purported generic equivalents), competition for our generic products (including from other pharmaceutical companies and as a result of increased governmental pricing pressures), competition for our specialty pharmaceutical businesses, our ability to achieve expected results through our specialty, including innovative, R&D efforts, the effectiveness of our patents and other protections for innovative products, decreasing opportunities to obtain U.S. market exclusivity for significant new generic products, our ability to identify, consummate and successfully integrate acquisitions, the effects of increased leverage as a result of recent acquisitions, the extent to which any manufacturing or quality control problems damage our reputation for high quality production and require costly remediation, our potential exposure to product liability claims to the extent not covered by insurance, increased government scrutiny in both the U.S. and Europe of our agreements with brand companies, potential liability for sales of generic products prior to a final resolution of outstanding patent litigation, our exposure to currency fluctuations and restrictions as well as credit risks, the effects of reforms in healthcare regulation and pharmaceutical pricing and reimbursement, any failures to comply with complex Medicare and Medicaid reporting and payment obligations, governmental investigations into sales and marketing practices (particularly for our specialty pharmaceutical products), uncertainties surrounding the legislative and regulatory pathways for the registration and approval of biotechnology based products, adverse effects of political or economical instability, corruption, major hostilities or acts of terrorism on our significant worldwide operations, interruptions in our supply chain or problems with our information technology systems that adversely affect our complex manufacturing processes, any failure to retain key personnel or to attract additional executive and managerial talent, the impact of continuing consolidation of our distributors and customers, variations in patent laws that may adversely affect our ability to manufacture our products in the most efficient manner, potentially significant impairments of intangible assets and goodwill, potential increases in tax liabilities, the termination or expiration of governmental programs or tax benefits, environmental risks and other factors that are discussed in our Annual Report on Form 20-F for the year ended December 31, 2012 and in our other filings with the U.S. Securities and Exchange Commission. Forward-looking statements speak only as of the date on which they are made and the Company undertakes no obligation to update or revise any forward looking statement, whether as a result of new information, future events or otherwise.
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SOURCE Teva Women's Health, Inc.