Pharmaceutical Development and Approval in the United States of Agents to Influence Cardiovascular Health

Author:

Cheeley Mary Katherine,Cavendish Laurie

Publisher

Springer International Publishing

Reference15 articles.

1. Schwartz GG, Steg PG, Szarek M, et al. Alirocumab and cardiovascular outcomes after acute coronary syndrome. N Engl J Med. 2018;379:2097–107.

2. Sabatine MS, Giugliano RP, Keech AC, et al. Evolocumab and clinical outcomes in patients with cardiovascular disease. N Engl J Med. 2017;376:1713–22.

3. Barter PJ, Caulfield M, Eriksson M, et al. Effects of torcetrapib in patients at high risk for coronary events. N Engl J Med. 2007;357:2109–22.

4. US Department of Health and Human Services. Food and Drug Administration. Center for Drug Evaluation and Research (CDER). Guidance for industry: hypertension indication: Drug labeling for cardiovascular outcome claims. 2011. https://www.fda.gov/media/134777/download#:~:text=This%20guidance%20is%20intended%20to%20assist%20applicants%20in,cardiovascular%20outcomes%20expected%20from%20such%20blood%20pressure%20reduction. Accessed 28 Jul 2023.

5. US Department of Health and Human Services. Food and Drug Administration. Center for Drug Evaluation and Research (CDER). Hypertension: conducting studies of drugs to treat patients on a background of multiple antihypertensive drugs: guidance for industry. 2018a. https://www.fda.gov/media/114731/download. Accessed 28 Jul 2023.

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