ANDA Approvals Break Record, May Set New Normal
FDA's June approval total is highest of GDUFA era, but does it signal a new elevated productivity level for the generics program?
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US FDA cut first-cycle review time 46% between fiscal year 2013 and FY 2015, but more than 900 ANDAs still awaited review by end of 2016.
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.
Prioritizing ANDAs entering markets with fewer than three approved generics not expected to become a major advantage until first-cycle clearances increase.