Table of Contents
HYDERABAD, India — Dr. Reddy’s Laboratories has started shipping over-the-counter fexofenadine HCl allergy relief tablets.
The pharmaceutical company said the Food and Drug Administration approved its Abbreviated New Drug Application (ANDA) for fexofenadine HCl tablets last week.
Plans call for Dr. Reddy’s to market the allergy medication under store-brand labels in the United States. The drug maker said the product is a bioequivalent version of sanofi-aventis’ Allegra tablets, which received prescription-to-OTC switch approval from the FDA in late January.
The fexofenadine HCl prescription drug market had brand and generic sales of about $452 million last year, according to IMS Health data cited by Dr. Reddy’s.
