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Naloxone Model OTC Label Expected From US FDA As Part Of Opioids Strategy

 
• By Eileen Francis

US FDA Anesthetic and Analgesic Drug Products and Drug Safety and Risk Management advisory committees meet in December to discuss proposed routes to make the opioid overdose reversal agent naloxone more available: both as an OTC product and one co-prescribed with opioids.

US FDA will publish a model OTC naloxone Drug Facts label “soon” to help switch sponsors developing labeling comprehension studies and final labeling, says Commissioner Scott Gottlieb.

The agency’s work on a Drug Facts label (DFL) for naloxone reflects its encouragement to drug companies to submit Rx-to-OTC...

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More from US FDA Performance Tracker

Novel US FDA Approvals Could Heat Up November, But Will Annual Count Beat 2024?

 
• By Bridget Silverman

Eight novel agents have user fee goal dates in November, which keeps the possibility of matching or topping the 2024 annual count alive.

Cidara’s Non-Vaccine Flu Preventive Offers Respite From Vaccine Conflicts

 
• By Bridget Silverman

Cidara's CD388 drug-Fc conjugate received a breakthrough designation as the Phase III ANCHOR trial started for once-per-season prevention of influenza in a higher-risk population.

October US FDA User Fee Goals: Few Novel Agents, But Many New Indications As Shutdown Looms

 
• By Bridget Silverman

October is unusually low on user fee goals for novel agents, but more than 20 applications for new indications and formulations will keep FDA staff busy, especially in oncology and ophthalmology.

J&J’s Inlexzo Is A Rare 505(b)(2) NDA To Qualify For US FDA’s Real-Time Oncology Review

 
• By Bridget Silverman

A Johnson & Johnson executive tells the Pink Sheet in an interview how the company developed its pretzel-shaped intravesical drug releasing system for gemcitabine, which used design and materials to improve efficacy and ease bladder cancer treatment.

More from Regulatory Trackers

October US FDA User Fee Goals: Few Novel Agents, But Many New Indications As Shutdown Looms

 
• By Bridget Silverman

October is unusually low on user fee goals for novel agents, but more than 20 applications for new indications and formulations will keep FDA staff busy, especially in oncology and ophthalmology.

EU CHMP Opinions And MAA Updates

 
• By Neena Brizmohun

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

J&J’s Inlexzo Is A Rare 505(b)(2) NDA To Qualify For US FDA’s Real-Time Oncology Review

 
• By Bridget Silverman

A Johnson & Johnson executive tells the Pink Sheet in an interview how the company developed its pretzel-shaped intravesical drug releasing system for gemcitabine, which used design and materials to improve efficacy and ease bladder cancer treatment.