Healthcare Industry News: Allergan
News Release - October 20, 2006
Allergan announces Health Canada grants medical device license to its two silicone-filled breast implant product linesMARKHAM, ON, Oct. 20 (Healthcare Sales & Marketing Network) - Allergan, Inc. (NYSE:AGN ) today announced that the company has been granted a medical device license with conditions by Health Canada to sell and market its INAMED(R) Silicone-Filled Breast Implants, including the INAMED(R) Round, Smooth and Textured Silicone-Filled Breast Implants and INAMED(R) Style 410 Shaped and Textured Silicone-Filled Breast Implants, for use in breast augmentation, reconstruction and revision surgery.
"This regulatory milestone is significant for Canadian women seeking breast implant surgery because they now have more options - the same options that women today have in more than 60 countries around the world," said Kevin Skule, President and General Manager, Allergan Canada. "In addition, by approving these products, Health Canada is acknowledging the vast body of scientific evidence supporting the safety of our products."
The INAMED(R) Silicone-Filled Breast Implant product line has been available to women outside Canada and the United States for more than 25 years. Health Canada approved the INAMED(R) Round, Smooth and Textured Silicone-Filled Breast Implants and the INAMED(R) Style 410 Shaped and Textured Silicone-Filled Breast Implants. The INAMED(R) Style 410 matrix is the next innovation in breast implant technology, utilizing a highly cohesive silicone gel that allows the breast implant to closely mimic the dimensions of the natural breast and has an innovative implant design that helps meet patient needs.
"As a plastic surgeon, I am frequently asked by my patients about silicone gel-filled breast implants. Having reviewed the clinical studies that support the approval of these products, I am very encouraged that Health Canada has appropriately approved their use, giving me greater flexibility to meet my patients' needs," said Dr. Frank Lista, plastic surgeon and Past President of the Canadian Society for Aesthetic Plastic Surgery.
For more information about INAMED(R) Silicone-Filled Breast Implants, please visit www.breastimplantstoday.ca. To learn more about Inamed, a division of Allergan, Inc., visit www.Allerganandinamed.com.
This press release contains "forward-looking statements", including the statements by Mr. Skule and Dr. Lista, and other statements regarding Allergan's clinical studies and the effectiveness of INAMED(R) Silicone-Filled Breast Implants. 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 and medical device market conditions; technological advances and patents attained by competitors; challenges inherent in the research and development and regulatory processes; challenges related to product marketing, such as the unpredictability of market acceptance for medical device products and/or the acceptance of product line extensions for such products; the potential for product failures; the unknown risks associated with the investigational devices that are the subject of Allergan's clinical trials; potential difficulties in manufacturing new products; and governmental laws and regulations affecting domestic and foreign operations. Additional information concerning these and other risk factors can be found in press releases issued by Allergan, as well as Allergan's public periodic filings with the Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in Allergan's 2005 Form 10-K and Allergan's Form 10-Q for the quarter ended June 30, 2006. Copies of Allergan's press releases and additional information about Allergan are available on the World Wide Web at www.Allergan.com or you can contact the Allergan Investor Relations Department by calling 1-714-246-4636.
About Allergan, Inc.
With more than 55 years of experience providing high-quality, science-based products, Allergan, Inc., with headquarters in Irvine, California, is a technology-driven, global health care company that discovers, develops and commercializes specialty pharmaceutical and medical device products in the ophthalmology, neurosciences, medical dermatology, medical aesthetics, obesity intervention and other specialty markets that deliver value to its customers, satisfy unmet medical needs, and improve patients' lives.
(R) Marks owned by Allergan, Inc.
Issuer of this News Release is solely responsible for its
Please address inquiries directly to the issuing company.
Related News ItemsAllergan Announces FDA Approval of AVYCAZ(R) (ceftazidime and avibactam) for Pediatric Patients
Allergan Announces FDA Acceptance of New Drug Application for Ubrogepant for the Acute Treatment of Migraine
FDA Accepts Supplemental Biologics License Applications (sBLAs) for BOTOX(R) (onabotulinumtoxinA) for Pediatric Patients with Upper and Lower Limb Spasticity