Roxane's Diazepam Intensol petition
FDA denied firm's petition for ANDA suitability of a 10 mg/ml oral solution concentrate, stating that proposed concentration is not appropriate for providing reasonable initial doses for the target or other likely population. Roxane had identified the elderly population as a primary target. FDA said dose for such patients "should be the smallest effective dose, with initial recommended doses not to exceed 2-2.5 mg".
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