FDA Exclusivity Protections Blocking ‘Me Too’ Product Challenged In Lawsuit
This article was originally published in The Pink Sheet Daily
Veloxis sues FDA after agency declines to approve to its extended-release immunosuppressant, Envarsus XR, until exclusivity for Astellas’ Astagraf XL expires in 2016.
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A roundup of the US FDA's drug approvals in the final weeks of 2018.
Female mortality rate among liver transplant patients had been a major obstacle to approval for extended-release tacrolimus, which was first filed in 2005. But the once-daily drug is now approved for kidney transplant patients.
The early February date for publishing the list of products eligible for price negotiations could dictate approval strategies going forward.