FDA is announcing the availability of Draft Guidance: Hypertension- Developing Fixed-Dose Combination Drugs for Treatment. This draft guidance will assist sponsors in the development of fixed-dose combination drugs for the treatment of hypertension.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.
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