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FDA Gives Makers of Unapproved Drugs Last Chance to Request Hearings

The FDA is giving manufacturers of prescription anti-spasmodic, gastrointestinal and hypertension medications that were cited as unapproved drugs decades ago until Aug. 23 to inform the agency if they still want to appeal its decision on the need for an NDA. Otherwise, their request will be withdrawn. The products in question were sold for decades and benefited from entering the market before 1962, when Congress mandated that all new drugs be proven safe and effective before being approved, the FDA said in a Federal Register notice published July 24.
Washington Drug Letter