FDA May Refuse Imports of Generic Drugs From Spanish Company for Failure to Pay User Fees
The Food and Drug Administration may refuse imports of pharmaceuticals from a Spanish company for failure to pay generic drug user fees, it said in a warning letter dated June 2. According to FDA, Leon-based generic drug manufacturer Antibioticos did…
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pay fees required by the Generic Drug User Fee Amendments of 2012 (GDUFA) for fiscal years 2013 and 2014. As a result, FDA has put Antibioticos on its GDUFA Arrears List (here), and says it may put the company on import alert and refuse imports of generic drugs exported by Antibioticos.