Ulesfia
Generic name: benzyl alcohol
Treatment for: Lice
Approvable Letter for Head Lice Treatment
Sciele Pharma Announces That the FDA Has Issued an Approvable Letter for the Head Lice Treatment
ATLANTA--(BUSINESS WIRE)--Jul 16, 2008 - Sciele Pharma, Inc. today announced that the U.S. Food & Drug Administration (FDA) has issued an approvable letter for the head lice treatment. Sciele Pharma is working closely with Summers Laboratories and the FDA to provide additional information that was requested.
About Sciele Pharma, Inc.
Sciele Pharma, Inc. is a pharmaceutical company specializing in sales, marketing and development of branded prescription products focused on Cardiovascular/Diabetes, Women's Health and Pediatrics. The Company's Cardiovascular/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, coughs and colds, and attention deficit/hyperactivity disorder (ADHD). Founded in 1992 and headquartered in Atlanta, Georgia, Sciele Pharma employs more than 900 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, Speed of Execution, Simplicity, and Teamwork.
About Summers Laboratories, Inc.
Summers Laboratories is a privately-held pharmaceutical company specializing in highly-targeted prescription and non-prescription products for pediatric and adult dermatology. Summers' leading brand is Triple Paste(R) Medicated Ointment for diaper rash. According to IRI data, Triple Paste is one of the fastest growing diaper rash treatments in the U.S. Triple Paste and other Summers Labs products are carried nationwide by the largest drugstore chains: Target, Wal-Mart and other major retailers. In addition to the lice asphyxiating product recently acquired by Sciele Pharma, Summers Laboratories is working on developing licensing or acquiring niche prescription and non-prescription dermatological products.
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 the Company believes the expectations expressed in these statements are reasonable, it cannot promise that these expectations will turn out to be correct. Actual results could be materially different from and worse than expectations.
Contact
Sciele Pharma, Inc.
Joseph T. Schepers, 678-341-1401
ir@sciele.com
Posted: July 2008
Related articles
- Sciele Pharma Announces FDA Approval of Benzyl Alcohol Lotion 5%, First Prescription Non-Neurotoxic Head Lice Treatment - April 13, 2009
- Sciele Provides Update on Head Lice Asphyxiation Product - February 20, 2008
- Sciele Pharma Announces FDA Acceptance of NDA for Summers Laboratories' Head Lice Treatment - August 16, 2007
Ulesfia (benzyl alcohol) FDA Approval History
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