Characteristics of Recent Generic Drug Approvals by the US Food and Drug Administration

Kuo Jiao; Ravi Gupta; Erin Fox; Aaron Kesselheim; Joseph S Ross

doi:10.1001/jamanetworkopen.2019.13029

Characteristics of Recent Generic Drug Approvals by the US Food and Drug Administration

JAMA Netw Open. 2019 Oct 2;2(10):e1913029. doi: 10.1001/jamanetworkopen.2019.13029.

Authors

Kuo Jiao^{1

2}, Ravi Gupta³, Erin Fox⁴, Aaron Kesselheim⁵, Joseph S Ross^{6

7

8}

Affiliations

¹ Yale University School of Public Health, New Haven, Connecticut.
² Now with Fosun Pharma, Princeton, New Jersey.
³ Department of Medicine, Johns Hopkins Hospital, Johns Hopkins School of Medicine, Baltimore, Maryland.
⁴ University of Utah Health Care Drug Information Service, Department of Pharmacotherapy, University of Utah College of Pharmacy, Salt Lake City.
⁵ Program On Regulation, Therapeutics, And Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
⁶ Section of General Internal Medicine, Department of Medicine, Yale University School of Medicine, New Haven, Connecticut.
⁷ Department of Health Policy and Management, Yale University School of Public Health, New Haven, Connecticut.
⁸ Center for Outcomes Research and Evaluation, Yale New Haven Hospital, New Haven, Connecticut.

Abstract

This cross-sectional study describes the characteristics of abbreviated new drug applications approved by the US Food and Drug Administration, focusing on those with limited generic competition or with history of shortages.

MeSH terms

Cross-Sectional Studies
Databases, Factual
Drug Approval / statistics & numerical data*
Drugs, Generic*
Economic Competition
Humans
United States
United States Food and Drug Administration / statistics & numerical data*

Substances

Drugs, Generic

Grants and funding

UL1 TR001863/TR/NCATS NIH HHS/United States