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Dr. Reddy's Files FDA Drugmaster Application For Nexium

Law360 (July 16, 2004, 12:00 AM EDT) -- Indian drug maker Dr. Reddy’s has made a preliminary filing with the U.S. Food and Drug Administration, paving the way for an application for a generic version of AstraZeneca's blockbuster heartburn medicine Nexium.

Dr Reddy's has filed a "drugmaster" document with the FDA, usually the precursor to a full-blown patent challenge. The submission of a drugmaster file with the FDA typically precedes an abbreviated new drug application (ANDA).

Dr. Reddy’s formal application could be prepared within six months to file for regulatory approval for its version...
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