Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims Guidance for Industry

Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims | FDA
Docket Number:

FDA-2008-D-0150

Issued by:
Guidance Issuing Office
Office of Medical Products and Tobacco, Center for Drug Evaluation and Research

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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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

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Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2008-D-0150.

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