Supplier News Breaks Archives
Allegra given green light to go OTC
January 25th, 2011
BRIDGEWATER, N.J., and CHATTANOOGA, Tenn. – The Food and Drug Administration has cleared popular allergy medication Allegra to become available over the counter starting next month.
Sanofi-aventis U.S. and its Chattem Inc. U.S. consumer health care arm said Tuesday that the FDA has approved the Allegra (fexofenadine) family of antihistamine products for nonprescription use in adults and children age 2 and older. Allegra-D, which relieves nasal congestion and sinus pressure as well, will also be available without a prescription at the pharmacy counter for use in adults and children 12 years of age and older.
Plans call for Allegra and Allegra-D to be available at drug, supermarket, mass merchandise and club stores nationwide in March in their original prescription strengths without a prescription, sanofi-aventis and Chattem said.
"Leveraging our U.S. consumer health care platform to convert prescription medicines to OTC products is a key growth driver for sanofi-aventis to become a diversified health care company also in the United States," stated Hanspeter Spek, president of global operations for sanofi-aventis. "The approval of Allegra for OTC use further validates our vision to increase our presence in the U.S. consumer health care market."
Allegra products to be available without a prescription include Allegra 24-Hour and 12-Hour Tablets for adults and children age 12 and older; Children's Allegra 12-Hour Tablets for kids age 6 and older; Children's Allegra 12-Hour Liquid for children age 2 and older; Children's Allegra 12-Hour Orally Disintegrating Tablets for kids age 6 and older; and Allegra-D® 24-Hour and 12-Hour Allergy and Congestion Extended Release Tablets (with a decongestant) for children age 12 and older.
"We're pleased to provide U.S. consumer access to Allegra, the No. 1 U.S.-prescribed allergy treatment, allowing allergy sufferers to conveniently obtain a safe and effective medication without a prescription," commented Zan Guerry, chief executive officer of Chattem.
Over 40 million adults suffer from indoor and outdoor allergies in the United States, the companies reported. Allegra is designed to provide fast, nondrowsy, 24-hour relief of allergy symptoms such as sneezing, runny nose, itchy and watery eyes, and itchy nose or throat.