FDA Gives Green Signal to Lupin's Famotidine for Oral Suspension

Oral-SuspensionThe US Food and Drug Administration (FDA) have finally approved the Lupin Pharmaceuticals, Inc.’s Abbreviated New Drug Application (ANDA) for famotidine for oral suspension. Lupin Pharmaceuticals, Inc. is the wholly-owned subsidiary of Lupin Limited and the official shipments of the product have already started.

The accepted drug Lupin's famotidine is the AB-rated generic similar to the Merck's Pepcid. The drug is for short term cure of active duodenal ulcer, gastro esophageal reflux disease or GERD and active benign gastric ulcer. The annual sales rate of Pepcid for oral suspension is US$ 29 million for the year ending March 2010, according to IMS Health sales data.

It was confirmed by Lupin that it has received a final green signal for new drug application or ANDA for Famotidine for Oral Suspension which is 40mg/ 5ml.

Company’s shares dipped Rs. 33.6, or 1.71%, at Rs. 1,932.50. On the whole the traded shares were 8,432 at the BSE. The average volume of shares traded on the bourses came out to be less by 94.36% to 8,432, as compared to the 22-day average volume of 149,565.

Last one month of Company’s stocks have performed exceptionally well and inclined 5.65% against Sensex’s 4.46% elevation. It also contended the market pretty well in past one quarter and profited 21.02% in opposition to
0.99% rise in the Sensex.