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Lupin's famotidine for oral suspension gets US FDA approval

Our Bureau, MumbaiThursday, July 1, 2010, 08:00 Hrs  [IST]

Lupin Pharmaceuticals, Inc., the US wholly-owned subsidiary of Lupin Limited has received final approval for the company's Abbreviated New Drug Application (ANDA) for famotidine for oral suspension (40 mg/ 5 ml) from the US Food and Drug Administration (FDA). Commercial shipments of the product have already commenced. Lupin's famotidine for oral suspension is the AB-rated generic equivalent of Merck's Pepcid indicated for the short-term treatment of active duodenal ulcer, active benign gastric ulcer, and gastroesophageal reflux disease (GERD). Pepcid for oral suspension had annual sales of approximately US$ 29 million for the twelve months ended March 2010, based on IMS Health sales data.

 
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