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News Details

01/07/2010 00:00

Lupin - Lupin receives FDA approval for Famotidine for Oral Suspension

Mumbai, July 01, 2010: Pharma Major, Lupin Limited announced today that its U,S subsidiary, Lupin Pharmaceuticals, Inc. (LPI) 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 œ29 million for the twelve months ended March 2010, based on IMS Health sales data,