Drug Rejection Hearings Are Having A Moment At US FDA
With Intarcia's request, the rarely used mechanism could now produce two hearings this year, but outcomes of the few other times the process has been undertaken should not generate a lot of confidence for sponsors that this a path that they want to go down.
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Sotagliflozin Hail Mary? Lexicon Seeks Opportunity For Formal Hearing On FDA Intent To Deny Approval
After complete response letter, Lexicon triggers rarely used mechanism for formal hearing, prompting US FDA to publicly list its problems with the proposed type 1 diabetes drug, for which Sanofi had originally sought approval.
Pharmaceutical Manufacturing Research Services argued that its immediate-release oxycodone should be approved with abuse-deterrent labeling while simultaneously asserting that abuse-deterrent labeling should only be permitted based on postmarketing studies, FDA notes.
Data on abuse deterrence for Pharmaceutical Manufacturing Research Services' oxycodone immediate-release product are insufficient, FDA tells company.