Granules Gets USFDA NOD For Allergy Treatment Drug

Drug firm Granules India on Monday said it has received approval from the US health regulator for Fexofenadine Hydrochloride tablets, used to treat allergy symptoms.

The approved product is bio-equivalent to the reference listed drug product (RLD), Allegra Allergy Tablets, 60 mg and 180 mg, of Sanofi-Aventis US LLC.

The US Food & Drug Administration (USFDA) has approved the abbreviated new drug application (ANDA) filed by Granules India for Fexofenadine Hydrochloride tablets USP in the strengths of 60 mg and 180 mg (OTC), Granules said in a regulatory filing. – Outlook India