Almost half the active ingredients on FDA’s list of off-patent, off-exclusivity drugs that lack generic competition involve complexities requiring agency consultation and action before an abbreviated new drug application (ANDA) is even submitted.
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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