Teva Identifies ‘Problem Pattern’ Of Complex CRLs Ahead Of GDUFA III

North America Head Brendan O’Grady Presses For Speedier Approvals

 
• By Dean Rudge
  
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Forecasting up to a dozen complex generic launches by Teva in the US in 2021, executive vice-president for North America commercial Brendan O’Grady said Teva was continuing to push for changes to boost approval rates ahead of GDUFA III next year.

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Teva says there are 12 complex products which it could debut in the US this year, but it won't get them all • Source: Shutterstock

Major complete response letters for complex abbreviated new drug application products are something of a “problem pattern,” Teva has told Generics Bulletin, with manufacturers keenly aware that there is “a lot of work to be done with the US Food and Drug Administration in speeding up that time to approval and keeping communication going back and forth” during the review process.

In the second part of Generics Bulletin’s exclusive interview with the Israeli generics giant, executive vice-president for North America commercial...

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