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FDA nod for Cheminor drug

HYDERABAD: Cheminor Drugs Ltd, belonging to Dr Reddy's group, has received tentative approval from the United States Federal Drug Administration (USFDA) for Famotidine tablets 10 mg. Famotidine tablets is for relief and prevention of heartburn and acid i ndigestion.

An over-the-counter (OTC) generic equivalent of Johnson & Johnson/Merck's Pepcid AC, Famotidine tablets had sales of approximately $225 million in the US in 1999. Cheminor will begin distributing and shipping the product immediately after Merck's exclusi vity expiration in 2001, according to a company press release here on Thursday.

The tentative approval for Famotidine tablets 10 mg is in addition to the tentative approval from USFDA to Cheminor for Famotidine tablets USP 20 mg and 40 mg prescription strengths recently. Cheminor currently manufactures and distributes Ranitidine tab lets 75 mg, an OTC version of Glaxo Wellcome's Zantac 75 through California-based Leiner Health Products. -- Our Bureau