Quartette™ Represents the Next Generation of Extended Regimen Oral Contraceptives
JERUSALEM, Israel I March 29, 2013 I Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) today announced that the U.S. Food and Drug Administration (FDA) has approved Quartette™ (levonorgestrel/ethinyl estradiol and ethinyl estradiol) tablets for the prevention of pregnancy. Quartette™ represents the next generation of extended regimen oral contraceptives to be approved by the FDA, and was designed to minimize breakthrough bleeding (BTB) between scheduled periods. The approval of Quartette™ demonstrates Teva’s continued commitment to the development and production of an innovative range of pharmaceutical products that support the health of women around the world.
“Breakthrough bleeding can be experienced with any birth control pill, especially during the first few months, and is one of the reasons a large number of women discontinue extended regimens,” said Dr. James A. Simon, clinical professor of Obstetrics and Gynecology at the George Washington University School of Medicine. “The estrogen in Quartette™ increases at specific points and provides four short light periods a year. Breakthrough bleeding decreases over time, which might help encourage patient adherence.”
The approval was based on a development program that included results from Phase I, Phase II and Phase III clinical trials designed to evaluate the safety and efficacy of Quartette™. The Phase III clinical trial, which involved more than 3,000 women, found that Quartette™ was 97 percent effective at preventing pregnancy. Data further demonstrated that the most common adverse reactions (≥2%) in the Phase III clinical trial were headaches, heavy/irregular vaginal bleeding, nausea/vomiting, acne, dysmenorrhea, weight increased, mood changes, anxiety/panic attack, breast pain and migraines. The primary clinical trial that evaluated the efficacy of Quartette™ also assessed BTB. BTB and unscheduled spotting decreased over successive 91 day cycles.1
Quartette™ features a unique 91-day oral regimen, whereby the dose of estrogen increases at three distinct points over the first 84 days and the amount of progestin remains consistent; this is followed by seven days of 10 mcg of ethinyl estradiol.
“Teva is the leader in the pharmaceutical industry in the marketing and development of extended regimen oral contraceptives, and Quartette™ represents the next generation of these contraceptives. It is a uniquely differentiated product and is based on Teva’s research into when breakthrough bleeding is most likely to occur with these regimens,” said Jill DeSimone, senior vice president & general manager, Global Teva Women’s Health. “Quartette™ is the newest product in our global women’s health franchise and is an example of our dedication to providing a variety of contraceptive and family planning options that fit women’s lifestyles.”
Important Safety Information for QuartetteTM
Quartette™ (levonorgestrel/ethinyl estradiol and ethinyl estradiol) tablets are indicated for use by women to prevent pregnancy.
IMPORTANT SAFETY INFORMATION
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.
- The use of hormonal birth control is associated with increased risks of several serious side effects, including blood clots, stroke, and heart attack.
- You should not take the pill if you have blood clots, certain cancers, a history of heart attack or stroke, undiagnosed abnormal bleeding, or may be pregnant.
- The most common side effects of Quartette™ are headaches, heavy/irregular vaginal bleeding, nausea/vomiting, acne, pain with bleeding, weight gain, mood changes, anxiety/panic attack, breast pain, and migraines.
- The pill does not protect against HIV infection (AIDS) and other sexually transmitted infections.
- The occurrence of fewer periods (4 per year instead of 13 per year) should be weighed against the occurrence of increased bleeding and/or spotting between periods. Unscheduled bleeding and unscheduled spotting should decrease over subsequent 91-day cycles.
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
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) is a leading global pharmaceutical company, committed to increasing access to high-quality healthcare by developing, producing and marketing affordable generic drugs as well as innovative and specialty pharmaceuticals and active pharmaceutical ingredients. Headquartered in Israel, Teva is the world’s leading generic drug maker, with a global product portfolio of more than 1,000 molecules and a direct presence in about 60 countries. Teva’s branded businesses focus on CNS, oncology, pain, respiratory and women’s health therapeutic areas as well as biologics. Teva currently employs approximately 46,000 people around the world and reached $20.3 billion in net revenues in 2012.
SOURCE: Teva Pharmaceutical Industries
Post Views: 63
Quartette™ Represents the Next Generation of Extended Regimen Oral Contraceptives
JERUSALEM, Israel I March 29, 2013 I Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) today announced that the U.S. Food and Drug Administration (FDA) has approved Quartette™ (levonorgestrel/ethinyl estradiol and ethinyl estradiol) tablets for the prevention of pregnancy. Quartette™ represents the next generation of extended regimen oral contraceptives to be approved by the FDA, and was designed to minimize breakthrough bleeding (BTB) between scheduled periods. The approval of Quartette™ demonstrates Teva’s continued commitment to the development and production of an innovative range of pharmaceutical products that support the health of women around the world.
“Breakthrough bleeding can be experienced with any birth control pill, especially during the first few months, and is one of the reasons a large number of women discontinue extended regimens,” said Dr. James A. Simon, clinical professor of Obstetrics and Gynecology at the George Washington University School of Medicine. “The estrogen in Quartette™ increases at specific points and provides four short light periods a year. Breakthrough bleeding decreases over time, which might help encourage patient adherence.”
The approval was based on a development program that included results from Phase I, Phase II and Phase III clinical trials designed to evaluate the safety and efficacy of Quartette™. The Phase III clinical trial, which involved more than 3,000 women, found that Quartette™ was 97 percent effective at preventing pregnancy. Data further demonstrated that the most common adverse reactions (≥2%) in the Phase III clinical trial were headaches, heavy/irregular vaginal bleeding, nausea/vomiting, acne, dysmenorrhea, weight increased, mood changes, anxiety/panic attack, breast pain and migraines. The primary clinical trial that evaluated the efficacy of Quartette™ also assessed BTB. BTB and unscheduled spotting decreased over successive 91 day cycles.1
Quartette™ features a unique 91-day oral regimen, whereby the dose of estrogen increases at three distinct points over the first 84 days and the amount of progestin remains consistent; this is followed by seven days of 10 mcg of ethinyl estradiol.
“Teva is the leader in the pharmaceutical industry in the marketing and development of extended regimen oral contraceptives, and Quartette™ represents the next generation of these contraceptives. It is a uniquely differentiated product and is based on Teva’s research into when breakthrough bleeding is most likely to occur with these regimens,” said Jill DeSimone, senior vice president & general manager, Global Teva Women’s Health. “Quartette™ is the newest product in our global women’s health franchise and is an example of our dedication to providing a variety of contraceptive and family planning options that fit women’s lifestyles.”
Important Safety Information for QuartetteTM
Quartette™ (levonorgestrel/ethinyl estradiol and ethinyl estradiol) tablets are indicated for use by women to prevent pregnancy.
IMPORTANT SAFETY INFORMATION
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.
- The use of hormonal birth control is associated with increased risks of several serious side effects, including blood clots, stroke, and heart attack.
- You should not take the pill if you have blood clots, certain cancers, a history of heart attack or stroke, undiagnosed abnormal bleeding, or may be pregnant.
- The most common side effects of Quartette™ are headaches, heavy/irregular vaginal bleeding, nausea/vomiting, acne, pain with bleeding, weight gain, mood changes, anxiety/panic attack, breast pain, and migraines.
- The pill does not protect against HIV infection (AIDS) and other sexually transmitted infections.
- The occurrence of fewer periods (4 per year instead of 13 per year) should be weighed against the occurrence of increased bleeding and/or spotting between periods. Unscheduled bleeding and unscheduled spotting should decrease over subsequent 91-day cycles.
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
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) is a leading global pharmaceutical company, committed to increasing access to high-quality healthcare by developing, producing and marketing affordable generic drugs as well as innovative and specialty pharmaceuticals and active pharmaceutical ingredients. Headquartered in Israel, Teva is the world’s leading generic drug maker, with a global product portfolio of more than 1,000 molecules and a direct presence in about 60 countries. Teva’s branded businesses focus on CNS, oncology, pain, respiratory and women’s health therapeutic areas as well as biologics. Teva currently employs approximately 46,000 people around the world and reached $20.3 billion in net revenues in 2012.
SOURCE: Teva Pharmaceutical Industries
Post Views: 63
