Aurobindo Pharma Ltd has received final approval from the US FDA to manufacture and market Famotidine tablets USP, 20 mg and 40 mg.
The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Pepcid tablets, 20 mg and 40 mg, of Valeant Pharmaceuticals International, Inc.
Famotidine tablets is used for the short-term treatment of gastroesophageal reflux disease and active duodenal ulcer The approved product has an estimated market size of US$ 29 million for the twelve months ending October 2015, according to IMS.
This is the 54th ANDA to be approved out of Unit VII formulation facility in Hyderabad, India for manufacturing oral non - antibiotic products. Aurobindo now has a total of 226 ANDA approvals (198 final approvals including 10 from Aurolife Pharma LLC and 28 tentative approvals) from US FDA.