How Long Has Praluent Been on the Market?
Praluent (alirocumab) was FDA approved July 24, 2015, and has been on the market over 9 years, with a cardiovascular indication added in April 2019.
Alirocumab: Regulatory History
7 source-based articles maintained by the HealthRX.com Editorial Team.
7articles
4topic areas covered
May 25, 2026latest review
Alirocumab: Regulatory History library
Showing 7 of 7 clinical reviews.
Praluent (Alirocumab) Compounding Legal Status: FDA Approval, Regulations, and What Patients Need to Know
Complete guide to Praluent (alirocumab) compounding legal status, FDA approval history, patent protections, and regulatory framework governing PCSK9 inhibitor access.
Praluent (Alirocumab) FAERS Safety Signals: Post-Market Surveillance Data and FDA Reports
A clinical review of alirocumab (Praluent) safety signals from the FDA Adverse Event Reporting System (FAERS), post-market surveillance findings, and label updates since approval.
Praluent (Alirocumab) Global Regulatory Status: FDA Approval, EMA Authorization, and Label Updates
Regulatory overview of Praluent (alirocumab): FDA approval history, EMA authorization, the ODYSSEY OUTCOMES cardiovascular indication, label changes, and what remains unverified in secondary summaries of this history.
Praluent (Alirocumab) Pipeline, FDA History, and Next-Generation PCSK9 Therapies
Complete regulatory timeline for Praluent (alirocumab), including FDA approval history, current label indications, post-market safety data, and next-generation PCSK9 inhibitor development.
Praluent (Alirocumab): EMA vs FDA Approval, Labeling, and Post-Market Oversight Compared
A side-by-side comparison of how the FDA and EMA regulate Praluent (alirocumab), covering approval timelines, label differences, indication scope, post-market surveillance, and safety monitoring.
Praluent (Alirocumab): Legal Challenges, Patent Battles, and Regulatory History
A detailed look at Praluent's FDA approval, the Amgen v. Sanofi patent dispute, label expansions, and what these legal and regulatory events mean for PCSK9 inhibitor access.