Teva to Present New Data on Women's Health Products at the American Congress of Obstetricians and Gynecologists Annual Clinical Meeting
Meeting to Feature Research in Overactive Bladder and Emergency Contraception
FRAZER, Pa., May 4, 2012 /PRNewswire/ -- Teva Women's Health today announced new data from the Company's expanding women's health franchise will be featured at the 60th Annual Clinical Meeting of the American Congress of Obstetricians and Gynecologists (ACOG) in San Diego, California, May 5-9, 2012. Featured presentations and abstracts will include new data on Plan B One-Step® (levonorgestrel) tablet 1.5mg, the only one pill emergency contraceptive available over-the-counter to women 17 years of age and older*, and results from the Phase II study evaluating oxybutynin vaginal ring for women with overactive bladder.
*Prescription required for women under age 17.
Featured presentations include:
- An assessment of young adolescents' ability to understand the key concepts needed for safe and effective over-the-counter use of emergency contraceptives
- An analysis of the effects of two doses of oxybutynin delivered by a monthly vaginal ring compared to placebo on Urogenital Distress Inventory (UDI) outcomes in women with overactive bladder
Platform Presentation/Poster Session Details:
Plan B One-Step®
- [P918] Can Young Adolescents Use Emergency Contraception Over-the-Counter? (Poster Session 1: Contraception/Family Planning – Number 10: Monday, May 7, 2012, 3:00-4:00 p.m. PDT) Tina R. Raine-Bennett, Oakland, CA; Nancy Ricciotti, MSN, North Wales, PA; Abby Sokoloff, MPH, San Francisco, CA
Oxybutynin Vaginal Ring
- [P353] Evaluation of the Urogenital Distress Inventory in Users of a Monthly Oxybutynin Vaginal Ring (Poster Session 1: Urogynecology – Number 100: Monday, May 7, 2012, 3:00-4:00 p.m. PDT) Bruce J. Levine, Moorestown, NJ; Kathleen Z. Reape; Sally M. Fedon, North Wales, PA
"We are pleased to contribute to the scientific exchange that makes the annual ACOG meeting such an important event for the thousands of physicians who have dedicated their careers to caring for the unique and diverse needs of women of all ages," said Nancy Ricciotti, Senior Director, Teva Women's Health R&D. "With our heritage in innovative reproductive health products and our current focus on evolving our business to meet the needs of the patient and provider communities, we are committed to continuing to evolve our specialized branded pharmaceutical franchises, of which women's health is a strong focus."
IMPORTANT SAFETY INFORMATION FOR PLAN B ONE-STEP® (levonorgestrel)
Plan B One-Step® is intended to prevent pregnancy after known or suspected contraceptive failure or unprotected intercourse.
Plan B One-Step® isn't effective if a woman is already pregnant, and it won't terminate an existing pregnancy. Plan B One-Step® does not protect against HIV and other sexually transmitted diseases (STDs). Side effects may include changes in period, nausea, lower abdominal pain, fatigue, headache, and dizziness. If your period is more than a week late, you may be pregnant. A woman should not take Plan B One-Step® if she is already pregnant. Plan B One-Step® should not be used as a routine birth control, as it is not as effective. If a woman experiences severe abdominal pain, she may have an ectopic pregnancy, and should get immediate medical help.
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.
Full prescribing information for Plan B One-Step® is available at http://www.planbonestep.com/pdf/PlanBOneStepFullProductInformation.pdf.
About Oxybutynin Vaginal Ring
Teva's investigational oxybutynin vaginal ring (DR-3001) is a flexible transvaginal ring that is designed to continuously release oxybutynin (a muscarinic receptor antagonist) throughout the month for the potential treatment of overactive bladder in female patients with symptoms of predominant or pure urge incontinence, urinary urgency, and elevated urinary frequency.
About Teva Women's Health
Teva Women's Health is the U.S.-based subsidiary of Teva Pharmaceutical Industries Ltd., 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 deep commitment to enhancing women's lives by providing distinct pharmaceutical options that meet women's needs.
Teva Women's Health is actively pursuing new areas of research in women's healthcare, including fertility and urinary incontinence, in addition to contraception and treatments for menopausal symptoms. 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 successfully develop and commercialize additional pharmaceutical products, the introduction of competing generic equivalents, the extent to which we may obtain U.S. market exclusivity for certain of our new generic products and regulatory changes that may prevent us from utilizing exclusivity periods, potential liability for sales of generic products prior to a final resolution of outstanding patent litigation, including that relating to the generic version of Protonix(R), the extent to which any manufacturing or quality control problems damage our reputation for high quality production, the effects of competition on sales of our innovative products, especially Copaxone(R) (including potential generic and oral competition for Copaxone(R)), the impact of continuing consolidation of our distributors and customers, our ability to identify, consummate and successfully integrate acquisitions (including the acquisition of Cephalon), interruptions in our supply chain or problems with our information technology systems that adversely affect our complex manufacturing processes, intense competition in our specialty pharmaceutical businesses, any failures to comply with the complex Medicare and Medicaid reporting and payment obligations, our exposure to currency fluctuations and restrictions as well as credit risks, the effects of reforms in healthcare regulation, adverse effects of political or economical instability, major hostilities or acts of terrorism on our significant worldwide operations, increased government scrutiny in both the U.S. and Europe of our agreements with brand companies, dependence on the effectiveness of our patents and other protections for innovative products, our ability to achieve expected results through our innovative R&D efforts, the difficulty of predicting U.S. Food and Drug Administration, European Medicines Agency and other regulatory authority approvals, uncertainties surrounding the legislative and regulatory pathway for the registration and approval of biotechnology-based products, potentially significant impairments of intangible assets and goodwill, potential increases in tax liabilities resulting from challenges to our intercompany arrangements, our potential exposure to product liability claims to the extent not covered by insurance, the termination or expiration of governmental programs or tax benefits, current economic conditions, any failure to retain key personnel or to attract additional executive and managerial talent, environmental risks and other factors that are discussed in our Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission.
Plan B One-Step® is a registered trademark of Women's Capital Corporation.
© 2012 Teva Women's Health, Inc.
SOURCE Teva Women’s Health
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