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FDA Requires New Label Warning of Weight Loss Risk in Pediatric Patients Taking Extended-Release Stimulants for ADHD

Psychiatric Times

SHOW MORE The FDA will update ADHD medication labels, warning of weight loss risks in children under 6, urging careful monitoring by health care professionals. Health care professionals should monitor the child’s growth and development and provide necessary interventions to mitigate weight loss.”

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NRx Pharmaceuticals Applies for FDA National Priority Voucher for Intravenous Ketamine (NRX-100)

Psychiatric Times

1 The newly announced CNPV pathway was introduced by FDA Commissioner Marty Makary, MD, MPH, on June 17, 2025, and is intended to expedite reviews for medications that address US public health priorities. 1 The company has previously filed the required Chemistry, Manufacturing, and Controls (CMC) information and received FDA feedback.