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Lupin gets US FDA approval for famotidine suspension

This article was originally published in Scrip

Executive Summary

Lupin's US subsidiary has received final US FDA approval of its ANDA for famotidine for oral suspension (40mg/5ml), a generic version of Merck & Co's H2-antagonist anti-ulcer product Pepcid for oral suspension. Pepcid is used for the short-term treatment of active duodenal ulcer, active benign gastric ulcer and gastro-oesophageal reflux disease. Lupin said that it had commenced shipments of its generic product. Pepcid for oral suspension had sales of about $29 million for the 12 months ended March 2010, according to IMS Health data cited by Lupin.



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