Teva Comments On Sandoz Implications Amid Strategic Review
Israeli Firm Has Ruled Itself Out Of Merging With Novartis Unit
Teva CEO Kåre Schultz has weighed in on Novartis’ plans to conduct a strategic review for its Sandoz unit, while also airing frustrations over continued delays for complex products in the US.
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The FDA believes conducting a pre-submission meeting when a complex generic application has unusual elements can increase the likelihood of a first-cycle approval.
Complex products are slowly gaining a larger share of ANDA submission and approval totals, which could mean the FDA has to adapt its in-house expertise to compensate.
Novartis finally has confirmed plans to begin a strategic review for its Sandoz generics and biosimilars business, following years of conjecture and suggestions from the market. However, the originator stressed that it will take its time with a decision, while underlining that keeping Sandoz is among its choices.