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BioPharmaceutical United States Approvals

FDA Exclusivity Protections Blocking ‘Me Too’ Product Challenged In Lawsuit

This article was originally published in The Pink Sheet Daily

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Executive Summary

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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Biden Administration’s regulatory freeze suspends HHS action to appoint an administrative dispute resolution board for the 340B program. Good news for manufacturers?

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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