New Draft Guidances: Innovative Approaches for Nonprescription Drugs/ Indications & Usage Section of Labeling / Studies of Drugs to Treat Patients on Multiple Antihypertensive Drugs

1. Innovative Approaches for Nonprescription Drug Products – Draft Guidance for Industry

This guidance describes two innovative approaches that may be useful to consider for demonstrating safety and effectiveness for a nonprescription drug product in cases where the drug facts labeling (DFL) alone is not sufficient to ensure that the drug product can be used safely and effectively in a nonprescription setting: (1) the development of labeling in addition to the DFL, and (2) the implementation of additional conditions so that consumers appropriately self-select and use the product. 

The appropriateness and specific details of either of these approaches will depend on the circumstances that apply to a particular drug product. These innovative approaches may be useful for applicants intending to develop and seek approval of certain nonprescription drug products through the submission of a new drug application (NDA), including an application submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355).

2. Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products — Content and Format – Draft Guidance for Industry

This guidance is intended to assist applicants in drafting the INDICATIONS AND USAGE section of labeling as described in the regulations for the content and format of labeling for human prescription drug and biological products. The purpose of this guidance is to help ensure that the INDICATIONS AND USAGE section is clear, concise, useful, and informative and, to the extent possible, consistent within and across drug and therapeutic classes. Applicants should follow the recommendations in this guidance when developing the INDICATIONS AND USAGE section for a new drug and when revising this section for a currently approved drug, including when seeking approval of a new indication.

3. Hypertension: Conducting Studies of Drugs to Treat Patients on Background of Multiple Antihypertensive Drugs - Draft Guidance for Industry

This guidance is intended to clarify the recommended approach for sponsors developing drugs to treat hypertension for patients who are on a background of multiple antihypertensive drugs.  Sponsors have approached FDA to discuss development programs for drugs intended to treat resistant hypertension, which sponsors have defined as hypertension not adequately controlled by maximally tolerated doses of three or more antihypertensive drugs with different mechanisms of action. FDA encourages development of additional classes of drugs for hypertension, particularly classes of drugs that demonstrate effects when added to currently available therapies.