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Sotagliflozin Hail Mary? Lexicon Seeks Opportunity For Formal Hearing On FDA Intent To Deny Approval

 
• By Derrick Gingery

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.

Dispute (lolloj/Shutterstock.com)
US FDA denied two formal requests for dispute resolution related to sotagliflozin after issuing a complete response letter to original application holder Sanofi . • Source: Shutterstock

Lexicon Pharmaceuticals, Inc. expects to request a formal hearing to overturn the US Food and Drug Administration’s rejection of sotagliflozin in type 1 diabetes, and clarify the product’s prospects in the disease.

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FDA Special Assistant Høeg’s Vaccine Concerns On Display At ACIP

 
• By Sue Sutter

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FDA Reorganization Proposal A ‘Mindless Approach To Centralization,’ Woodcock Says

 
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