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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.
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. 1 NRx appears to be committed to the mental health space.
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.
Borderline PersonalityDisorder “No Longer Has a Place in Clinical Practice” Image depicts the thoughts and behaviors typically associated with BPD. In June, Micah Ingle wrote that researchers from the UK and New Zealand argue that Borderline PersonalityDisorder should be abandoned as a diagnostic category.
We cited research based on the clinical study reports the manufactures had submitted to drug regulators to get their drugs approved for children and adolescents and other research in our letter. 4,5 I asked Emslie and the manufacturer, Eli Lilly, if they wanted to restore the trials. The fraud was grave.
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