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US FDA’s First Competitive Generic Therapy Approval Comes With A Twist

 
• By Sue Sutter

Apotex’s potassium chloride oral solution is eligible for 180-day exclusivity under new expedited pathway even though Amneal’s generic referencing same product was approved three weeks earlier; Amneal's continued marketing will not be blocked by Apotex’s exclusivity, which is forfeited if it fails to launch within 75 days.

The US FDA’s first approval under the Competitive Generic Therapy pathway came with a twist – it followed the approval just weeks earlier of a first generic, from a different sponsor, to the same reference product.

On Aug. 8, the agency approved Apotex Inc.’s abbreviated new drug application (ANDA) for potassium chloride oral solution, which...

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• By Eliza Slawther

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EU Decision Time For Madrigal’s MASH Drug Resmetirom And 11 Others

 
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Blenrep’s Comeback Continues As England Becomes First To Fund Drug

 
• By Eliza Slawther

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Kisunla Back In The Spotlight As EMA Reconsiders Alzheimer’s Drug Rejection

 
• By Eliza Slawther

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Post-Approval, Real-Time Monitoring Will Help Approval Standards, US FDA’s Makary Says

 
• By Sue Sutter

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EU Decision Time For Madrigal’s MASH Drug Resmetirom And 11 Others

 
• By Eliza Slawther

Madrigal Pharmaceuticals’ resmetirom could become the first approved treatment for non-cirrhotic metabolic dysfunction-associated steatohepatitis in the EU, if the European Medicines Agency issues a positive opinion for the drug later this week.