Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims

15 December 2022 – the FDA published final guidance on drug labeling for cardiovascular outcome claims for hypertension.

This guidance is intended to assist applicants in developing labeling for cardiovascular outcome claims for drugs that are indicated to treat hypertension. With few exceptions, current labeling for antihypertensive drugs includes only the information that these drugs are indicated to reduce blood pressure; the labeling does not include information on the clinical benefits related to cardiovascular outcomes expected from such blood pressure reduction.

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