Hypertension: Developing Fixed-Dose Combination Drugs for Treatment Guidance for Industry

Hypertension: Developing Fixed-Dose Combination Drugs for Treatment Guidance for Industry

	The Division of Drug Information (DDI) - serving the public by providing information on human drug products and drug product regulation by FDA

FDA is announcing the availability of Draft Guidance: Hypertension- Developing Fixed-Dose Combination Drugs for Treatment. This draft guidance will assist sponsors in the development of fixed-dose combination drugs for the treatment of hypertension. Many people with hypertension need more than one drug to control their blood pressure and fixed-dose drug combinations may help simplify their treatment and minimize potential side effects. The guidance focuses on development of fixed dose two-drug combinations of previously approved drugs.  For more information, please visit: Draft Guidance: Hypertension- Developing Fixed-Dose Combination Drugs for Treatment