Watson Laboratories, Inc.; Proposal To Withdraw Approval of an Abbreviated New Drug Application for Oxycodone Hydrochloride and Ibuprofen Tablets; Opportunity for a Hearing

摘要

The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research (CDER) is proposing to withdraw approval of an abbreviated new drug application (ANDA) for oxycodone hydrochloride and ibuprofen tablets and is announcing an opportunity for the holder of the ANDA to request a hearing on this proposal. The basis for the proposal is that the holder of the ANDA has repeatedly failed to submit the required data to support a finding of bioequivalence for this ANDA.