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FDA Panel Votes Against Primatene Reboot Due To Safety Concerns

 
• By Elizabeth Crawford

Concerns about safety prompt an FDA advisory panel to recommend against approving Armstrong Pharmaceutical’s NDA for an OTC emergency asthma inhaler. Concerns about device malfunction and about a potentially inaccurate dose indicator also influence the panel.

Concerns about insufficient safety data and device malfunction led a joint panel of FDA experts Feb. 25 to recommend against OTC use of Armstrong Pharmaceutical Inc.’s reformulated emergency asthma inhaler.

A joint panel of the Nonprescription Drugs and Pulmonary-Allergy Drugs advisory committees voted 18-6 against approving Primatene HFA actuated, or breath-triggered, epinephrine inhalation aerosol.The panel also voted 17-7 that Armstrong...

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More from United States

US FDA’s June Approval Forecast: Infection Prevention, Cancer And HAE

 
• By Bridget Silverman

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GLP-1 Pricing ‘Paradigm Shift’ Possible, But Would It Meet Trump’s MFN Goals?

 
• By Cathy Kelly

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Pink Sheet Podcast: US FDA’s Private Pharma CEO Tour, HHS Changes COVID-19 Vaccine Advice

 
• By Derrick Gingery, Sarah Karlin-Smith, Sue Sutter, and Nielsen Hobbs

Pink Sheet reporter and editors consider the issues that could emerge during upcoming private FDA forums with pharma CEOs, as well as the impact of the surprising move by HHS Secretary Robert F. Kennedy Jr. to limit the CDC recommendation for annual COVID-19 vaccine boosters.

US FDA’s ‘Good Reputation’ For Science May Mean Loper Bright Not ‘Cataclysmic,’ Attorney Says

 
• By Malcolm Spicer

Bridget Dooling, a law school professor who reviewed draft regulations from the FDA and other agencies as an OMB attorney, said prior federal court decisions suggest judges typically defer to agency decisions based in science.

More from North America

US FDA’s ‘Good Reputation’ For Science May Mean Loper Bright Not ‘Cataclysmic,’ Attorney Says

 
• By Malcolm Spicer

Bridget Dooling, a law school professor who reviewed draft regulations from the FDA and other agencies as an OMB attorney, said prior federal court decisions suggest judges typically defer to agency decisions based in science.

US FDA’s Prasad: ‘We Will Always Embrace Surrogate Endpoints’

 
• By Sarah Karlin-Smith

The new CBER director, once best known in the pharma world for criticizing accelerated approval, committed to expediting cancer drugs with surrogate endpoints.