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 FDA has seemingly followed the lead of the EMA by guiding ANDA sponsors on how to develop oligonucleotide drugs, a complex class of DNA or RNA molecules.
Health Canada approves Ryaltris for allergic rhinitis, opening up yet another major market for Glenmark’s branded specialty medicine. Bausch Health will sell the drug in Canada.
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.