Navigating the Trends in USFDA Authorized Generic Approvals (2019-2024): Enhancing Healthcare Accessibility and Affordability.

Objective: This study examines trends in USFDA's authorized generic (AG) approvals from January 2019 to August 2024, focusing on approval patterns, leading therapeutic areas, dominant dosage forms, and key companies. The research aims to highlight market dynamics and the role of AGs in enhancing healthcare accessibility and affordability with case studies.

Methods: Data was collected from the FDA's list of authorized generic drugs and analyzed to identify trends in annual approvals, therapeutic areas, and dosage forms.

A Comprehensive Retrospective Analysis of Trends and Strategic Implications of 505(b)(2) Approvals (2019-2023).

Background: The 505(b)(2) pathway, established by the USFDA, enables faster approval of new drug applications (NDAs) by allowing partial reliance on existing clinical data. This regulatory mechanism fosters innovation by encouraging new formulations, combinations, and delivery systems, accelerating the availability of advanced therapeutics.

Objective: This study provides a comprehensive analysis of 505(b)(2) NDA approvals from 2019 to 2023, with an emphasis on trends, major players, therapeutic targets, and dosage form diversity.