FDA Corrects Withdrawal of Approval for 70 New Drug Applications and 97 Abbreviated New Drug Applications

Summary

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on June 8, 2011, regarding the withdrawal of approval for 70 new drug applications (NDAs) and 97 abbreviated new drug applications (ANDAs) from multiple applicants, effective July 8, 2011. The FDA withdrew approval of three ANDAs after receiving a request from A.H. Robins Co., c/o Wyeth Pharmaceuticals, Inc., but later corrected the decision after PBM Pharmaceuticals, Inc. acquired the rights to the ANDAs and withdrew the request.