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FDA Form 483 – Esperion Therapeutics Inc (Samer Kazziha, MD)
FDA Form 483 – Esperion Therapeutics Inc (Samer Kazziha, MD)
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Original Request: Request 483 information for Samer Kazziha, MD, Cardiovascular Consultants, PC Esperion Therapeutics Inc, Protocol # 1002-043 Title of Project: A randomized double-blind, placebo-controlled study to assess the effects of Bempedoic Acid (ETC=1002) on the occurrence of major cardiovasular events in patient with, or at high risk for, cardiovascular disease who are statin intolerant. Thank you.
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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