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# Guide on Developing Hypertension Combo Drugs
- URL: https://www.fdaweb.com/guide-on-developing-hypertension-combo-drugs/
- Published: 2018-11-06T12:00:00.000Z
- Updated: 2026-09-15T00:42:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142754

FDA has released a [guidance](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM593825.pdf?ref=fdaweb.com) on “Hypertension: Developing Fixed-Combination Drug Products for Treatment.” The document focuses on developing two-drug combinations of previously approved drugs, the agency says, adding that the general approach is readily applicable to three or more drugs in combination. It does not address combinations that include unapproved drug products. “In considering fixed-combination drug products,” the document says, “FDA recognizes the interest both in (**1**) developing combinations of less than full doses of drug products with distinct mechanisms of action (e.g., a diuretic combined with an angiotensin-converting enzyme inhibitor, an angiotensin-receptor blocker, or a betablocker) that could be used as initial therapy; and (**2**) providing a range of combinations that allow dose titration to attain adequate blood pressure control.”