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.