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

Psychiatric Times

Manufacturers of extended-release stimulants that currently do not have a Limitation of Use section in the labeling will be required to add one about this risk, and manufacturers that do already have a Limitation of Use section will be required to revise the labeling to ensure consistent messaging.

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

Psychiatric Times

2 In a press release, NRx Pharmaceuticals said NRX-100 is well positioned for this designation, citing its alignment with national health priorities such as addressing the mental health crisis, innovating treatment for unmet needs, and enhancing domestic drug manufacturing.

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June in Review: Updates on the Psychiatric Treatment Pipeline

Psychiatric Times

A recently filed patent on its preservative-free manufacturing process may further support market exclusivity. Additionally, the company plans to file a citizen petition with the FDA to withdraw preservative-containing forms of ketamine, citing concerns about benzethonium chloride toxicity.