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US FDA Serves Notice: Approval Of OTC Naloxone Could Close Prescription Sales

 
• By Malcolm Spicer

Agency signals assurance about making naloxone available OTC, so much so that firms with approved NDAs for Rx products should prepare for an all-nonprescription market. After offering model label to spur OTC switch NDAs, FDA notice about OTC assessment is second unprecedented step on its naloxone journey since opioid crisis declared a public health emergency in 2017.

• Source: Shutterstock

The US Food and Drug Administration took a second unprecedented step in spurring development of OTC naloxone products by publishing a notice identifying data and other information needed in new drug applications for nonprescription access.

In a notice published on 15 November requesting comments, the agency signals that it is becoming assured about making naloxone available OTC, so much so that firms with approved...

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EMA: ‘Sad To See’ Member States Against Patient Engagement Under EU Pharma Reform

 
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The European Medicines Agency’s chief medical officer Steffen Thistrup argued that patients are able to understand the “complex regulatory and scientific issues” that the EMA committees discuss when they assess drugs.

Pfizer’s All-Comers CRPC Dream For Talzenna Quashed For Lack Of Biomarker-Negative Rigor

 
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Darzalex Faspro Gains US FDA AdComm Support For Smoldering Myeloma Claim

 
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The FDA may have violated laws and regulations along with many norms in how it released its planned changes for COVID-19 vaccine approvals.

More from Pathways & Standards

Darzalex Faspro Gains US FDA AdComm Support For Smoldering Myeloma Claim

 
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Novavax’s COVID-19 Vaccine Label Narrowed After Political Officials Intervened

 
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The label that Novavax's COVID-19 vaccine was slated to receive before political officials held up the approval was broader than was granted 16 May.