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Dr Reddy's nizatidine generic gets FDA nod


20 September,2005: India's Dr Reddy's Laboratories Ltd has received approval from the U.S. Food and Drug Administration to market nizatidine tablets in multiple strengths, according to a statement.

The gastrointestinal drug is a generic version of Axid-AR, manufactured by Whitehall-Robins Healthcare, the consumer health care division of American Home Products Corp. 

Nizatidine belongs to a relatively new class of over-the-counter medications known as acid reducers, which inhibit the release of acid in the stomach. In its prescription form, Axid is the fastest growing brand of oral H2-receptor antagonists in hospitals. Based on brand sales during the 52 week period prior to over-the-counter (OTC) status, this is the third largest prescription (Rx) to OTC switch in U.S. history.

Last year, Americans spent nearly $1 billion to treat their heartburn with over-the-counter remedies, such as antacids. Now, the stomach remedy market has undergone radical transformation with the recent introduction of nonprescription H2-blockers. Industry analysts expect that introduction of the acid reducers AXID AR, Tagamet HB, Pepcid AC, and Zantac 75 will grow the category considerably. In the 11 months following market entry of the first OTC H2-blockers, dollar sales of the stomach remedy category increased by 46 percent versus one year ago, says reports.

Whitehall-Robins Healthcare is a leader in the research and development, manufacturing, and marketing of consumer health care products in areas including analgesics, cough, cold, allergy remedies, and family planning. Its parent company, American Home Products, is one of the world's largest research-based pharmaceutical and health care products companies and is a leading developer, manufacturer, and marketer of prescription drugs, over-the-counter medications, agricultural products, medical devices, animal health care, and food products.



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