Understanding Recent Changes to 505(b)(2) Drugs and Reimbursement
Pharmacy Times
JUNE 23, 2025
Additionally, ANDA submissions should extrapolate the RLD safety and effectiveness data for drugs with the same active ingredients, dosage forms, strengths, routes, and labeling. From 2003 to 2023, 943 drugs were approved through the 505(b)(2) pathway. However, 505(b)(2) drugs have been available since the 1980s. “CMS
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