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US FDA proposes to withdraw approval of 249 abbreviated new drug applications

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US FDA proposes to withdraw approval of 249 abbreviated new drug applications

The U.S. Food and Drug Administration has proposed withdrawing the approval of 249 abbreviated new drug applications filed by various companies.

An abbreviated new drug application, or ANDA, seeks approval for a generic version for an existing licensed medication or approved drug. Companies filing for an ANDA must demonstrate that their product works in the same manner as the approved drug.

The FDA's Center for Drug Evaluation and Research made the decision due to the companies repeatedly failing to file required annual reports for these applications.

Companies whose applications were flagged in a notice posted on the Federal Register include Abbott Laboratories, Pfizer Inc. and Johnson & Johnson.

The companies have an option to request a hearing by Feb. 10, or they could opt to submit all data, information and analyses upon which the request for a hearing relies by March 9.