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Dr. Reddy’s wins generic Zantac approval

This article was originally published in The Tan Sheet

Executive Summary

FDA approves Dr. Reddy's Laboratories abbreviated new drug application to manufacture and market generic OTC versions of ranitidine 150 mg tablets acid indigestion treatment (GlaxoSmithKline's Zantac), Dr. Reddy's announces Sept. 13. The Hyderabad, India-based drug firm says the approval marks its first U.S. drug approval since it unveiled plans in May to launch a store-brand OTC business unit in the country. The firm is set to expand its OTC product portfolio and additional product introductions in the coming months which will include Rx switches and select OTC monograph products, the firm's North American Generics President Mark Hartman said...

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