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Primatene Mist NDA Expected By July After FDA OKs OTC Asthma Inhaler Trial

 
• By Malcolm Spicer

Amphastar plans this month to begin what it expects to be its final study to support an NDA to relaunch Primatene Mist. If the results support accurate self-selection and usage of the product by consumers, Amphastar should be ready to re-submit the NDA during the current quarter.

Young Doctor With Digital Tablet

Amphastar Pharmaceuticals Inc. expects by July to try again with a new drug application to FDA to relaunch Primatene Mist OTC emergency asthma inhaler after receiving an agency "green light" on a clinical trial.

Amphastar received a general advice letter from FDA on its planned clinical trial to support an NDA for Primatene Mist...

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• By Eliza Slawther

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The US FDA says its release of complete response letters for products subsequently approved by the agency is just a first step toward releasing rejection letters when they are issued, assuming legal issues can be resolved.

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• By Sue Sutter

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More from Pathways & Standards

Danish Medicines Agency Wants Companies To Use “Better Data Format” To Submit Bioequivalence Studies

 
• By Anabel Costa-Ferreira

The Danish Medicines Agency is requesting that data from bioequivalence studies to be submitted in the CDISC format in addition to the current eCTD format. It believes the move will make it easier for the agency claims to access and analyze data and will reduce the burden for applicants.

NDA User Fees Will Grow 8.6% Next Year As FDA Projects More Applications But Fewer Sponsor Meetings

 
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Expedited Reviews For China-Originated Drugs Shift Back Home

 
• By Xu Hu

The proportion of China-originated drugs granted expedited reviews in China doubled in the first half of this year, Pharmaprojects data show, surpassing those receiving similar treatment in the US and likely driven by multiple factors.