ANDAs For Drug/Device Combos Face High Bar At US FDA; Epipen, Advair May Benefit
Generics must be able to be administered without provider intervention or patient retraining, draft guidance says.
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Stayin’ Alive: GSK Sees Options For Brand Advair In A Post-Generic World
Payers might be open to keeping the Advair brand on formulary even if a generic becomes available, because GSK has a portfolio of respiratory drugs to leverage in negotiations, CEO Andrew Witty said during the company’s third quarter conference call.
Complex ANDAs To Be Allowed Pre-Submission Product Meetings
FDA will be able to give scientific advice and sponsors can familiarize reviewers with upcoming generic applications for complex products under new provision in GDUFA II.
EpiPen Generics: Woodcock Explains Injector Studies
In response to Congressional questions about whether FDA is a barrier to competition for the epinephrine product, CDER Director lays out what could be required to prove an injector device problem is fixed.