FDA Publishes List of Off-Patent/Off-Exclusivity Drugs Without Generic Competition

“Today, the U.S. Food and Drug Administration is taking two new, important steps to increase competition in the market for prescription drugs and facilitate entry of lower-cost alternatives. The agency published a list of off-patent, off-exclusivity branded drugs without approved generics, and also implemented, for the first time, a new policy to expedite the review of generic drug applications where competition is limited.” Here’s the full story, including the list and the new policy which “describes how the review of abbreviated new drug applications (ANDAs), ANDA amendments, and ANDA supplements will be prioritized for review within the Office of Generic Drugs (OGD) and the Office of Pharmaceutical Quality (OPQ).”

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