Report

Trends in Drug Shortages and ANDA Approvals in the U.S.

Trends in Drug Shortages and ANDA Approvals in the U.S.

Pages 19 Pages

This research brief examines persistent drug shortages in the U.S., particularly affecting generic and injectable medicines. It analyzes the relationship between FDA ANDA approvals and delayed or unlaunched generics, revealing economic and manufacturing barriers that limit market entry. The report highlights supply chain fragility, low pricing incentives, and long launch timelines as key contributors. It concludes with recommendations to strengthen incentives and resilience to improve drug availability.

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