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Its FDA-approved to improve blood sugar in adults with type 2 diabetes and to reduce the risk of major cardiovascular events (like heart attack or stroke) in adults with type 2 diabetes and established heart disease
A 1-year randomized controlled trial in 130 Alzheimer's patients found that ALCAR treatment (dosage not specified in abstract) resulted in slower rates of deterioration across 13 of 14 outcome measures, with statistical significance achieved for memory, intelligence, attention, and functional scales
The lawful basis here is patient-specific 503A personalization for a documented clinical need, confirmed by the February 21, 2025 shortage end and the April 1, 2026 clarification that B12 add-ons alone do not automatically qualify a script
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There is a chance the FDA could force pharmaceutical companies to act
