FDA rejects Advancis drug filing

The FDA indicated that Advancis’ application was not sufficiently complete in that it did not include a proposed commercial batch record or a detailed commercial process description with process parameters and in-process controls.

Advancis said it intends to meet with the FDA to discuss the issues raised and to reach agreement on what additional information is required for the filing to be accepted. The agency, however, did not raise any clinical or other issues in its communication.

“We are very surprised to learn of the FDA’s decision not to accept our application, and we regret the delay this will cause in our Amoxicillin PULSYS regulatory review,” said Dr Edward Rudnic, Advancis president and CEO.

“However, as the concerns communicated by the agency relate to manufacturing issues, and not clinical data, we believe we will be able to address the concerns relatively quickly and limit the delay in re-submitting our NDA.”