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Hypertension Drugs Draft Guidance
07/13/2018
 

FDA has posted a draft guidance entitled “Hypertension: Conducting Studies of Drugs to Treat Patients on a Background of Multiple Antihypertensive Drugs.” The document is intended to clarify the recommended approach for sponsors developing such drugs. “Sponsors have approached FDA to discuss development programs for drugs intended to treat resistant hypertension, which sponsors have defined as hypertension not adequately controlled by maximally tolerated doses of three or more antihypertensive drugs with different mechanisms of action,” the guidance says. “FDA encourages development of additional classes of drugs for hypertension, particularly classes of drugs that demonstrate effects when added to currently available therapies.


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