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Covis Waffles On Narrowing Makena Label After CDER Points Out Contradictions In Proposal

 
• By Sarah Karlin-Smith

Covis outside counsel says the company is open to working with the FDA on an appropriate label update for Makena after CDER staff got Covis to concede its proposed labeling change doesn’t meet the data standard for FDA approval.

makena waffles
• Source: Shutterstock

Covis Pharma appeared to make a mid-hearing strategy shift on what it wants the US Food and Drug Administration to do with the approval of its preterm birth drug Makena, which the company is trying to save from complete market withdrawal by proposing a narrower indication.

The move might have been a swift attempt by Covis to try and climb itself out of a hole the...

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