HYDERABAD, India – Dr. Reddy's Laboratories has rolled out levocetirizine tablets (5 mg) in the United States.
The India-based pharmaceutical maker said Monday that the Food and Drug Administration approved its abbreviated new drug application (ANDA) for the antihistamine tablets, available in 90-count bottles, on Feb. 24.
According to Dr. Reddy's, the product is the bioequivalent generic version of UCB/sanofi-aventis' Xyzal tablets in the U.S. market. The medication treats allergy symptoms as well as chronic hives.
Levocetirizine had total U.S. sales of about $238 million for the 12 months ended September 30, 2010, according to IMS Health cited by Dr. Reddy's.