From USFDA
Aurobindo Pharma announced that the Company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Famotidine Tablets USP, 10 mg and 20 mg (OTC). This product is expected to be launched in Q2 FY16-17.The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Pepcid AC Tablets, 10 mg and 20 mg, of McNeil Consumer Pharmaceuticals Co.
Famotidine Tablets (OTC) is used to relieve heartburn associated with acid indigestion and sour stomach. The approved product has an estimated market size of US$ 31 million for the twelve months ending February 2016 according to IMS.
This is the 73rd ANDA (including 16 tentative approvals) to be approved out of Unit VII formulation facility in Hyderabad, India for manufacturing Oral Non-Antibiotic products. Aurobindo now has a total of 256 ANDA approvals (219 Final approvals including 10 from Aurolife Pharma LLC and 37 tentative approvals) from USFDA.
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