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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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.
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.
Post-warning letter meetings for manufacturing issues and updates to the complex product meeting process are included in the user fee extension agreement.