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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Generic Drugs: First-Cycle Review Times Improve, But Hundreds Of ANDAs Still Pending
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.
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.
FDA Drug Pricing Policy Offers Short-Term PR Gain, More Long-Term Actual Benefit
Prioritizing ANDAs entering markets with fewer than three approved generics not expected to become a major advantage until first-cycle clearances increase.