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Approved Nearly 75 Years Ago, Bufferin NDA on Withdrawal Notice Due to Registration Lapse, Pharma Intelligence

Sunday, November 27, 2022

Partner Rebecca Dandeker was quoted in a Pharma Intelligence article about the US Food and Drug Administration’s recent announcement that it intends to withdraw its decades-old approval of a new drug application for Bufferin, citing failure by the application holder to file required annual reports with the agency. Rebecca, among other things, told the publication about the impact of a withdrawal.

“The holder of the NDA loses the opportunity to manufacture and market the product, in the way that the product is described in the NDA (i.e., formulation and labeling),” Rebecca said.

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