Inhaler Changes For Environmental Reasons Worry Generic Sponsors, Prompt Call For FDA Research
ANDA sponsors say eliminating the HFC propellant, while important to help address climate change, could upend the generic market without guidance from the US FDA.
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GDUFA Research Impacting Generic Development, ANDA Approvals
Increases in approved ANDAs that were affected by GDUFA research shows the importance of the US FDA’s regulatory science program.
Viatris Acknowledges Potential For US Symbicort Opportunity In 2022
Following its recent landmark approval for the first US generic version of AstraZeneca’s Symbicort blockbuster, Viatris has commented on the potential to move on a pre-patent expiry launch, amid a recent favorable court decision.
Growing Complex Generic Application Load May Force US FDA Staffing Changes
Complex products are slowly gaining a larger share of ANDA submission and approval totals, which could mean the FDA has to adapt its in-house expertise to compensate.