Sciele Pharma Announces FDA Acceptance of NDA for Summers Laboratories' Head Lice Treatment
ATLANTA, Aug 16. -- Sciele Pharma, Inc. today announced that the U.S. Food & Drug Administration (FDA) has accepted the New Drug Application (NDA) submitted by Summers Laboratories for a head lice asphyxiation product that utilizes a novel mechanism of action. Sciele acquired the rights to this product for the United States, Canada, and Mexico, and Summers submitted its NDA for this patented treatment on June 15, 2007.
Upon FDA approval, it will be the first prescription medication that kills head lice by asphyxiation instead of utilizing a neurotoxic pesticide. The prescription lice treatment market generated approximately $50 million in sales last year (according to IMS Health's National Prescription Audit Plus(TM) data), and the over-the-counter lice treatment market is several times larger.
This product is a simple, water-based, water-soluble gel, similar in consistency to a hair conditioner. It consists of a mixture of dermatological and cosmetic ingredients. Lice need oxygen to live and breathe through sophisticated spiracles. Lice can close their spiracles and go into suspended animation for many hours. This novel product contains a naturally occurring monohydric aralkyl alcohol, which prevents lice from closing their spiracles, thereby asphyxiating the lice within ten minutes.
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.
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