Approvals and Timing of New Formulations of Novel Drugs Approved by the US Food and Drug Administration Between 1995 and 2010 and Followed Through 2021.

ABSTRACT:

Importance

New formulations of prescription drugs can improve convenience and tolerability for patients, but they also constitute manufacturer strategies to extend brand-name drug market exclusivity periods.

Objective

To examine whether new formulations of brand-name novel drugs were associated with novel drugs' sales and/or therapeutic value, as well as characterize first new formulations' approval timing relative to the novel drug's generic approval.

Design setting and participants

This cross-sectional study used the Drugs@FDA database to identify all novel tablet and capsule drugs approved by the US Food and Drug Administration (FDA) between 1995 and 2010 and followed through December 31, 2021.

Exposures

Novel drugs' blockbuster status, defined as annual sal

SUBMITTER: Gupta R 

PROVIDER: S-EPMC9123500 | biostudies-literature | 2022 May

REPOSITORIES: biostudies-literature