Generic Industry Gets 267 Reasons From FDA To Pursue ANDA Development
US agency’s list of off-patent, off-exclusivity drugs that lack generic versions is aimed at improving transparency and encouraging competition, but almost half the 267 listed products involve complex issues that would require further decision-making by FDA ahead of ANDA submission.
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Opportunities for generic competition have been highlighted by the FDA, in the latest update to its list of products that are not protected by patents or exclusivities but have no approved rivals.
US agency is seeking feedback from interested stakeholders about administrative steps it can take to better promote generic competition; July 18 meeting will involve only presentations from the public.
Report sponsored by Association for Accessible Medicines in US says drugs with restricted distribution programs had total sales of $22.7bn in 2016; seven drugs had sales topping $1bn.