BOTOX(R) (onabotulinumtoxinA) Receives U.S. Food And Drug Administration Approval For The Treatment Of Overactive Bladder For Adults Who Have An Inadequate Response To Or Are Intolerant Of An Anticholinergic Medication
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.
About Allergan, Inc.Allergan is a multi-specialty health care company established more than 60 years ago with a commitment to uncover the best of science and develop and deliver innovative and meaningful treatments to help people reach their life’s potential. Today, we have approximately 10,500 highly dedicated and talented employees, global marketing and sales capabilities with a presence in more than 100 countries, a rich and ever-evolving portfolio of pharmaceuticals, biologics, medical devices and over-the-counter consumer products, and state-of-the-art resources in R&D, manufacturing and safety surveillance that help millions of patients see more clearly, move more freely and express themselves more fully. From our beginnings as an eye care company to our focus today on several medical specialties, including eye care, neurosciences, medical aesthetics, medical dermatology, breast aesthetics, obesity intervention and urologics, Allergan is proud to celebrate more than 60 years of medical advances and proud to support the patients and physicians who rely on our products and the employees and communities in which we live and work. For more information regarding Allergan, go to: www.allergan.com.Forward-Looking StatementsThis press release contains “forward-looking statements,” including the statements by Dr. Whitcup, Dr. Nitti and other statements regarding research and development and regulatory outcomes, efficacy, adverse reactions, market and product potential, product availability and other statements regarding BOTOX ®. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Allergan's expectations and projections. Risks and uncertainties include, among other things, general industry, biologic and pharmaceutical market conditions; technological advances and patents attained by competitors; challenges inherent in the research and development and regulatory processes; challenges related to new product marketing, such as the unpredictability of market acceptance for new pharmaceutical and biologics products and/or the acceptance of new indications for such products; inconsistency of treatment results among patients; potential difficulties in manufacturing a new product; and governmental laws and regulations affecting domestic and foreign operations. Allergan expressly disclaims any intent or obligation to update these forward-looking statements except as required by law. Additional information concerning these risks and other risk factors can be found in press releases issued by Allergan, as well as Allergan's public filings with the Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in Allergan's most recent Form 10-K and any subsequent Quarterly Reports on Form 10-Q. © 2013 Allergan, Inc. Irvine, CA 92612. ® marks owned by Allergan, Inc. All rights reserved. Myobloc ® is a registered trademark of Solstice Neurosciences, Inc. Dysport ® is a registered trademark of Ipsen Biopharm, Ltd. Xeomin ® is a registered trademark of Merz Pharma Gmbh & Co. *Dr. Nitti received research support for conducting BOTOX® clinical trials at NYU Langone and is a member of an advisory board for Allergan, Inc. 1 BOTOX® Prescribing Information, updated January 2013 2 Stewart WF, Van Rooyen JB, Cundiff GW, et al. Prevalence and burden of overactive bladder in the United States. World J Urol 2003:20:327-336; based on 2010 U.S. Census data and U.S. adult population [as of Jan. 10, 2013] 3 National Patient Count, IMS Total Patient Tracker, USC 24100, MAT 11/12 4 D’Souza et al. Persistence, Adherence, and Switch Rates Among Extended-Release and Immediate-Release Overactive Bladder Medications in a Regional Managed Care Plan. J. Managed Care Pharm. 2008;14(3):291-301 5 Allergan data on file 6 Allergan data on file; Global Medical Affairs 7 Allergan data on file; Global Safety and Epidemiology 8 Allergan data on file; Global Literature & Information Services and Global Regulatory Affairs
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