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 Brendan O’Grady discussed complex generics, both from Teva’s commercial standpoint and considering the planned reauthorization next year of