Mumbai, Jul 19 : Pharma Major, Dr. Reddy's Labs today announced an over-thecounter (OTC) store-brand equivalent of Allegra-D® 12 HR Allergy and Congestion Extended-Release Tablets has got approval by the U.S. Food and Drug Administration (USFDA).
Dr Reddy's OTC Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg Extended-Release Tablets, USP, are used for temporary relief of symptoms due to hay fever or other upper respiratory allergies that include runny nose; sneezing; itchy, watery eyes; itching of the nose or throat and for temporary relief of nasal congestion due to the common cold, hay fever or other upper respiratory allergie, Company said in a filing with BSE.
It is also used to reduce swelling of nasal passages, for temporary relief of sinus congestion and pressure and to temporarily restore freer breathing through the nose. "We are pleased to be expanding our pseudoephedrine-based product offering in time for the cough, cold and allergy season," says Milan Kalawadia, Senior Vice President and Head of US OTC and Specialty Rx Divisions, Dr. Reddy's Laboratories. "We look forward to collaborating with our customers to provide high-quality, affordable alternatives to consumers."
The Allegra-D 12 HR Allergy and Congestion Extended-Release Tablets brand and generic had U.S. sales of approximately $44 million MAT for the most recent twelve months ending in May 2019 according to IRi. Dr. Reddy's OTC Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg Extended-Release Tablets, USP are available in 20- and 30-count sizes.
Allegra-D 12 HR is a trademark of Aventisub II Inc. (UNI)