FDA Directs On Glenmark’s Ryaltris With New Batch Of Guidances
AbbVie’s JAK Inhibitor Rinvoq One Of 19 Revised Product-Specific Guides
A batch of four dozen new and revised product-specific guidances for generic products has been published by the US Food and Drug Administration, spanning a range of routes, dosages, and therapeutic areas.
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The latest tranche of product-specific guidances for generic development has been published by the US FDA, following two released in March and May this year.
Viatris remains committed to completing the sale of its global biosimilars unit to Biocon Biologics, while continuing efforts to generate up to $9bn in pre-tax proceeds by the end of 2023 from divestments.
Viatris is committing to earlier EBITDA and free cash flow targets for 2022, although it now expects to lose a chunk of revenues for the full year amid severe and sustained foreign currency exposure.