Allergan plc a leading global pharmaceutical company 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.
"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 Tria
In 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 ALLERGAN PLC
Allergan plc 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.