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Cuvposa

Generic name: glycopyrrolate
Treatment for: Chronic Drooling in Children

Update: Cuvposa (glycopyrrolate) Oral Solution Now FDA Approved - July 28, 2010

NDA Submitted for Glycopyrrolate Oral Solution

Sciele Pharma Submits New Drug Application to FDA for Glycopyrrolate Oral Solution, a Treatment for Chronic, Moderate-to-Severe Drooling in Pediatric Patients

ATLANTA--(BUSINESS WIRE)--Sep 28, 2009 - Sciele Pharma, Inc., a Shionogi company, today announced that it has submitted a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for glycopyrrolate oral solution to treat chronic, moderate-to-severe drooling in pediatric patients. This condition often results from cerebral palsy as well as from other neurological disorders.

Ed Schutter, President and Chief Operating Officer of Sciele Pharma, said, "We are pleased to announce the filing of this NDA for glycopyrrolate oral solution, which represents further diversification of our pediatric product portfolio. Upon approval, this product may provide a meaningful benefit to pediatric patients, especially children with cerebral palsy, who suffer from chronic, moderate-to-severe drooling."

Glycopyrrolate oral solution has received orphan drug designation from the FDA. The FDA's orphan drug designation is intended to provide incentives to encourage the development of drugs for diseases affecting fewer than 200,000 people in the U.S. Following FDA approval, the Orphan Drug Act provides drug market exclusivity for a period of seven years for a product's orphan indication.

About Sciele Pharma, Inc.

Sciele Pharma, Inc., a Shionogi Company, is a pharmaceutical company specializing in sales, marketing and development of branded prescription products focused on the therapeutic areas of Cardiovascular, Diabetes, Women's Health and Pediatrics. The Company's Cardiovascular and Diabetes products treat patients with high cholesterol, hypertension, high triglycerides, unstable angina and type 2 diabetes; its Women's Health products are designed to improve the health and well-being of women and mothers and their babies; and its Pediatrics products treat allergies, asthma and attention deficit and hyperactivity disorder (ADHD). Founded in 1992 and headquartered in Atlanta, Georgia, Sciele employs approximately 1,000 people. The Company's success is based on placing the needs of patients first, improving health and quality of life, and implementing its business platform – an Entrepreneurial Spirit, Innovation, Execution Excellence, Simplicity, and Teamwork. For more information on Sciele, please visit www.sciele.com.

About Shionogi & Co., Ltd.

Shionogi & Co., Ltd., headquartered in Osaka, Japan, is a major research-driven pharmaceutical company dedicated to placing the highest value on patients. Shionogi's Research and Development currently targets three therapeutic areas: Infectious Diseases, Pain, and Metabolic Syndrome. The Company has provided such innovative medicines as Crestor and Doripenem, which have been successfully delivered to millions of people who need them. In addition, Shionogi is engaged in some new research areas such as allergy and cancer. Contributing to the health of patients around the world through development in these therapeutic areas is Shionogi's primary goal. For more details, please visit www.shionogi.co.jp.

 

Safe Harbor Statement

This press release contains forward-looking statements that are subject to risks and uncertainties that could cause actual results to materially differ from those described. Although we believe that the expectations expressed in these statements are reasonable, we cannot promise that our expectations will turn out to be correct. Our actual results could be materially different from and worse than our expectations.

Contact: Sciele Pharma, Inc.

Joseph T. Schepers, +1-678-341-1401

ir@sciele.com

 

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Posted: September 2009

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