What’s Next? Five Things To Look Out For In October
Mylan And Upjohn Merger May Complete
In October, the period during which Mylan may complete its merger with Upjohn will begin, while the FDA will begin holding monthly stakeholder meetings ahead of the third iteration of the Generic Drug User Fee Amendments program, also known as GDUFA III.
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A trial will begin next month in Mylan’s bid to overcome patents shielding AstraZeneca’s Symbicort respiratory brand in the US. With rival Teva having previously settled ANDA action, Mylan is in the driving seat for a first substitutable generic.
Shortly after agreeing to divest three mature Upjohn brands in Australia, Mylan and the Pfizer off-patent and mature brands unit have stepped closer to merging into Viatris, bagging another key regulatory approval that had been in the works for several months.
The FDA has called on public stakeholders to notify the agency of their participation in the next Generic Drug User Fee Amendments program, as it sets the agenda for improving the generic drug approval process, including for complex generics.