Aurobindo Pharma Limited is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Famotidine Tablets USP, 20 mg and 40 mg.
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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.
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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 USFDA.
