DUBLIN, Nov. 10, 2016 /PRNewswire/ -- Allergan plc, (NYSE: AGN) a leading global pharmaceutical company, today announced the availability of TAYTULLA™ (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules), 1mg/20mcg, the first and only oral contraceptive in a softgel capsule for the prevention of pregnancy.
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"As a leader in women's healthcare, we are pleased to bring to market TAYTULLA, the first and only oral contraceptive in a softgel capsule, providing women with an important new and effective option to consider with their healthcare providers," said Bill Meury, Chief Commercial Officer at Allergan. "The patented softgel technology of TAYTULLA was designed with absorption and solubility in mind, contains 20 mcg of estrogen, and offers women pregnancy prevention with short, light periods."
TAYTULLA will be commercially available in blister cards containing 24 oval, opaque, pale pink (active) soft gelatin capsules, each containing 1 mg norethindrone acetate and 20 mcg ethinyl estradiol, and 4 oval, opaque, maroon (nonhormonal placebo) capsules containing iron.
For more information about TAYTULLA, visit www.TAYTULLA.com.
About the Clinical TrialIn a clinical study, 743 women 18 to 45 years of age were studied to assess the efficacy of norethindrone acetate/ethinyl estradiol tablets, for up to six 28-day cycles providing a total of 3,823 treatment-cycles of exposure. A total of 583 women completed 6 cycles of treatment. There were a total of 5 on-treatment pregnancies in 3,565 treatment cycles during which no backup contraception was used. The Pearl Index for norethindrone acetate/ethinyl estradiol capsules was 1.82 (95% CI: 0.59-4.25).
About TAYTULLA™INDICATIONS AND USAGETAYTULLA is an estrogen/progestin combination oral contraceptive (COC) indicated for use by females of reproductive age to prevent pregnancy. Efficacy in women with a body mass index (BMI) of more than 35 kg/m2 has not been evaluated.
IMPORTANT SAFETY INFORMATIONWARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTSCigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs should not be used by women who are over 35 years of age and smoke.
ContraindicationsTAYTULLA is contraindicated in pregnant patients and those with a high risk of arterial or venous thrombotic diseases, liver tumors (benign or malignant) or liver disease, undiagnosed abnormal uterine bleeding, or breast cancer or other estrogen- or progestin-sensitive cancer, now or in the past.
Warnings and PrecautionsDiscontinue TAYTULLA if a thrombotic event occurs, and at least 4 weeks before and through 2 weeks after major surgery. TAYTULLA should not be started any earlier than 4 weeks after delivery, in women who are not breastfeeding. If jaundice occurs, treatment should be discontinued.
TAYTULLA should not be prescribed for women with uncontrolled hypertension or hypertension with vascular disease. Women, who are pre-diabetic or diabetic, should be monitored while using TAYTULLA. Alternate contraceptive methods should be considered for women with uncontrolled dyslipidemia. Patients using TAYTULLA who have a significant change in headaches or irregular bleeding or amenorrhea should be evaluated.
Adverse ReactionsIn the clinical trial for TAYTULLA, the most common adverse reactions (incidence ?2%) were headache, vaginal candidiasis, nausea, menstrual cramps, breast tenderness, bacterial vaginitis, abnormal cervical smear, acne, mood swings, and weight gain.
Patients should be counseled that COCs do not protect against HIV infection (AIDS) and other sexually transmitted diseases.
For Full Prescribing Information, visit www.taytulla.com.
ABOUT ALLERGAN WOMEN'S HEALTHCARE
Allergan is a leader in women's health care that is dedicated to developing and commercializing best-in-class pharmaceuticals to improve the health and wellness of women. Allergan takes a holistic and a best-in-class approach to women's healthcare as it prioritizes educational partnerships with OB/GYNs. The mission of Allergan Women's HealthCare extends beyond its pharmaceutical products to ensure that all women can make informed decisions about their health and have access to high-quality medications. Allergan is committed to investing in programs that support the education and well-being of all women.
ABOUT ALLERGAN PLC
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a bold, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceuticals, devices and biologic products for patients around the world.
Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories.
Allergan is an industry leader in Open Science, the Company's R&D model, which defines our approach to identifying and developing game-changing ideas and innovation for better patient care. This approach has led to Allergan building one of the broadest development pipelines in the pharmaceutical industry with 70+ mid-to-late stage pipeline programs in development.
Our Company's success is powered by our more than 16,000 global colleagues' commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what is right.
With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.
For more information, visit Allergan's website at www.Allergan.com.
Forward-Looking Statement
Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Allergan's current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Allergan's current expectations depending upon a number of factors affecting Allergan's business. These factors include, among others, the difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Allergan's products; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Allergan's periodic public filings with the Securities and Exchange Commission, including but not limited to Allergan's Annual Report on Form 10-K for the year ended December 31, 2015 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2016 (certain of such periodic public filings having been filed under the "Actavis plc" name). Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.
CONTACTS:
Investors:Lisa DeFrancesco(862) 261-7152
Allergan Media:Mark Marmur(862) 261-7558
Lisa Kim(714) 246-3843
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"As a leader in women's healthcare, we are pleased to bring to market TAYTULLA, the first and only oral contraceptive in a softgel capsule, providing women with an important new and effective option to consider with their healthcare providers," said Bill Meury, Chief Commercial Officer at Allergan. "The patented softgel technology of TAYTULLA was designed with absorption and solubility in mind, contains 20 mcg of estrogen, and offers women pregnancy prevention with short, light periods."
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TAYTULLA will be commercially available in blister cards containing 24 oval, opaque, pale pink (active) soft gelatin capsules, each containing 1 mg norethindrone acetate and 20 mcg ethinyl estradiol, and 4 oval, opaque, maroon (nonhormonal placebo) capsules containing iron.
For more information about TAYTULLA, visit www.TAYTULLA.com.
About the Clinical TrialIn a clinical study, 743 women 18 to 45 years of age were studied to assess the efficacy of norethindrone acetate/ethinyl estradiol tablets, for up to six 28-day cycles providing a total of 3,823 treatment-cycles of exposure. A total of 583 women completed 6 cycles of treatment. There were a total of 5 on-treatment pregnancies in 3,565 treatment cycles during which no backup contraception was used. The Pearl Index for norethindrone acetate/ethinyl estradiol capsules was 1.82 (95% CI: 0.59-4.25).
About TAYTULLA™INDICATIONS AND USAGETAYTULLA is an estrogen/progestin combination oral contraceptive (COC) indicated for use by females of reproductive age to prevent pregnancy. Efficacy in women with a body mass index (BMI) of more than 35 kg/m2 has not been evaluated.
IMPORTANT SAFETY INFORMATIONWARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTSCigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs should not be used by women who are over 35 years of age and smoke.
ContraindicationsTAYTULLA is contraindicated in pregnant patients and those with a high risk of arterial or venous thrombotic diseases, liver tumors (benign or malignant) or liver disease, undiagnosed abnormal uterine bleeding, or breast cancer or other estrogen- or progestin-sensitive cancer, now or in the past.
Warnings and PrecautionsDiscontinue TAYTULLA if a thrombotic event occurs, and at least 4 weeks before and through 2 weeks after major surgery. TAYTULLA should not be started any earlier than 4 weeks after delivery, in women who are not breastfeeding. If jaundice occurs, treatment should be discontinued.
TAYTULLA should not be prescribed for women with uncontrolled hypertension or hypertension with vascular disease. Women, who are pre-diabetic or diabetic, should be monitored while using TAYTULLA. Alternate contraceptive methods should be considered for women with uncontrolled dyslipidemia. Patients using TAYTULLA who have a significant change in headaches or irregular bleeding or amenorrhea should be evaluated.
Adverse ReactionsIn the clinical trial for TAYTULLA, the most common adverse reactions (incidence ?2%) were headache, vaginal candidiasis, nausea, menstrual cramps, breast tenderness, bacterial vaginitis, abnormal cervical smear, acne, mood swings, and weight gain.
Patients should be counseled that COCs do not protect against HIV infection (AIDS) and other sexually transmitted diseases.
For Full Prescribing Information, visit www.taytulla.com.
ABOUT ALLERGAN WOMEN'S HEALTHCARE
Allergan is a leader in women's health care that is dedicated to developing and commercializing best-in-class pharmaceuticals to improve the health and wellness of women. Allergan takes a holistic and a best-in-class approach to women's healthcare as it prioritizes educational partnerships with OB/GYNs. The mission of Allergan Women's HealthCare extends beyond its pharmaceutical products to ensure that all women can make informed decisions about their health and have access to high-quality medications. Allergan is committed to investing in programs that support the education and well-being of all women.
ABOUT ALLERGAN PLC
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a bold, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceuticals, devices and biologic products for patients around the world.
Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories.
Allergan is an industry leader in Open Science, the Company's R&D model, which defines our approach to identifying and developing game-changing ideas and innovation for better patient care. This approach has led to Allergan building one of the broadest development pipelines in the pharmaceutical industry with 70+ mid-to-late stage pipeline programs in development.
Our Company's success is powered by our more than 16,000 global colleagues' commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what is right.
With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.
For more information, visit Allergan's website at www.Allergan.com.
Forward-Looking Statement
Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Allergan's current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Allergan's current expectations depending upon a number of factors affecting Allergan's business. These factors include, among others, the difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Allergan's products; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Allergan's periodic public filings with the Securities and Exchange Commission, including but not limited to Allergan's Annual Report on Form 10-K for the year ended December 31, 2015 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2016 (certain of such periodic public filings having been filed under the "Actavis plc" name). Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.
CONTACTS:
Investors:Lisa DeFrancesco(862) 261-7152
Allergan Media:Mark Marmur(862) 261-7558
Lisa Kim(714) 246-3843
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