Aurobindo Pharma Ltd has received final approval from USFDA to manufacture and market Famotidine Tablets used for acid reflux treatment. The approval has been granted for Famotidine Tablets of 20 mg and 40 mg strengths. The drug is bioequivalent and therapeutically equivalent to the reference listed drug product Pepcid Tablets, 20 mg and 40 mg, of Valeant Pharmaceuticals International, Inc. Famotidine Tablets are used for the short-term treatment of gastroesophageal reflux disease and active duodenal ulcer. The estimated market size is around USD 29 million.
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