Business Daily from THE HINDU group of publications
Friday, Sep 14, 2007
ePaper
Business Daily from THE HINDU group of publications Friday, Sep 14, 2007 ePaper |
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Corporate
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Regulatory Bodies & Rulings
Our Bureau Hyderabad, Sept. 13 Dr Reddy’s Laboratories Ltd has announced that the US Food and Drug Administration (USFDA) has granted final approval for its Abbreviated New Drug Application (ANDA) for Ranitidine (Zantac) 150mg tablet (Over-the-Counter). The Hyderabad-based pharma major is the only generic manufacturer to receive FDA approval for this product following the expiry of innovators patents. This is the first approval for the company’s, OTC business unit in the US, following an announcement in mid-May, to launch a Store Brand OTC Division in that country. Commenting on the approval, Mr Mark Hartman, President, North America Generics said, “We are excited about the Ranitidine 150mg approval as it will complement our Ranitidine 75mg OTC entry. This approval will help establish Dr Reddy’s in the US OTC business segment.” The company has plans to expand its OTC product portfolio and additional introductions are planned in the coming months that will certainly include Rx switches and select OTC Monograph products, he said. The company will distribute the 150mg strength in blister counts of 8 & 24s as well as bottles of 50, 65 and 95 counts, a communiqué to the stock exchanges said. More Stories on : Regulatory Bodies & Rulings | Pharmaceuticals | Dr. Reddy's Laboratories Ltd
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