1. Generics Bulletin
  2. >>Products
  3. >>Generics

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

North America Head Brendan O’Grady Presses For Speedier Approvals

 
• By Dean Rudge

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.

US Flag
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...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Generics Bulletin for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Generics

Welch Heads Up Par Ahead Of Planned Spin-Off After Endo-Mallinckrodt Merger

 
• By Dave Wallace

As Endo and Mallinckrodt continue to work towards consummating the merger they announced earlier this year, the pair have revealed further organizational details of their combined generics and sterile injectables business, which is set to be spun off after the merger is complete.

Generic Drug Office’s Policy Staff Returning To US FDA

 
• By Derrick Gingery

The group had been laid off as part of the 1 April reduction-in-force, which lead to missed guidance publication deadlines.

Stelara Biosimilar Sees Stada’s Specialty Sales Start Strong In Q1

 
• By Dave Wallace

Stada’s Specialty division was boosted by the firm’s launch last year of a European Stelara biosimilar, even as generics growth remained muted in Q1.

Lupin Concedes To Wakix IP With 2030 Launch Date Agreement

 
• By Dean Rudge

Ahead of a bench trial beginning in February 2026, Lupin has become the latest ANDA sponsor to settle patent-infringement litigation over Harmony Biosciences’ Wakix (pitolisant hydrochloride), which has been touted as a potential blockbuster by the end of the decade.

More from Products

Generic Drug Office’s Policy Staff Returning To US FDA

 
• By Derrick Gingery

The group had been laid off as part of the 1 April reduction-in-force, which lead to missed guidance publication deadlines.

Stelara Biosimilar Sees Stada’s Specialty Sales Start Strong In Q1

 
• By Dave Wallace

Stada’s Specialty division was boosted by the firm’s launch last year of a European Stelara biosimilar, even as generics growth remained muted in Q1.

Formycon Snatches Brazilian Approval For Lucentis Biosimilar

 
• By Urtė Fultinavičiūtė

Formycon is preparing to start a new era – entering Latin America with its ranibizumab biosimilar, which is expected to be a “good contributor” to the firm’s finances.