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Dosage Pediatric Patients Anxiety Disorders Oral Children 6 months of age: Manufacturer recommends initial dosage of 12.5 mg 3 or 4 times daily

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27 Most recently, on August 3, 2018, FDAs CDER issued a draft guidance entitled, Nonclinical Testing of Orally Inhaled Nicotine Containing Drug Products.28 The guidance provides sponsors of NDAs with recommendations on the nonclinical information necessary to support development and approval for orally inhaled nicotine-containing products