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Epithalon is not approved for human use in non-research settings

By conducting a pediatric study under a Written Request from the FDA, a brand manufacturer earns six months appended to any existing exclusivity or patent protection, including PTE-extended patents

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Mechanisms involved are thought to include tracheal microaspiration of acid stimulating bronchospasm 30 and increased airway hyper-reactivity associated with acid reflux into the lower esophagus

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