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Generic Industry Gets 267 Reasons From FDA To Pursue ANDA Development

 
• By Sue Sutter

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.

Syringes stuck in a dartboard

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.

Of 267 drug products, 121 (45%) involve “potential legal, regulatory, or scientific issues which should be addressed with the

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• By Michael McCaughan

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• By Dave Wallace

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