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Every batch undergoes High-Performance Liquid Chromatography (HPLC) analysis to verify purity levels (typically 98%), complemented by Mass Spectrometry (MS) for molecular weight confirmation

Splitting doses disrupts this pharmacokinetic profile and reduces effectiveness without improving tolerability

Review Type: 351(k) BLA, Standard Review Submission Date: July 6, 2024 (Resubmission) Review Status: FDA previously issued a complete response letter in August 2022

Kaminski 2020

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It creates smaller injection volumes but requires more precision when measuring