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GUIDANCE DOCUMENT

Hypertension: Developing Fixed-Dose Combination Drugs for Treatment November 2018

Final

Hypertension: Developing Fixed-Dose Combination Drugs for Treatment

Docket Number:
FDA-2018-D-3860
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Hypertension: Developing Fixed-Combination Drug Products for Treatment.” The purpose of this guidance is to assist sponsors in the clinical development of fixed-combination drug products for the treatment of hypertension. The guidance focuses on development of two-drug combinations of previously approved drug products. This guidance incorporates the comments received for and finalizes the draft guidance for industry entitled “Hypertension: Developing Fixed-Dose Combination Drugs for Treatment” issued on January 26, 2018.


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All written comments should be identified with this document's docket number: FDA-2018-D-3860.