A.P. Pharma Receives FDA Complete Response Letter for APF530

A Complete Response Letter is issued by the FDA's Center for Drug Evaluation and Research when the review of a file is completed and questions remain that preclude the approval of the NDA in its current form. The primary points raised in the FDA Complete Response Letter are discussed below

:Dosing System- The FDA expressed concerns relating to A.P. Pharma's two-syringe administration system, including potential issues with the transfer of material from one syringe to the other syringe prior to patient administration, certain components used in the dosing system and the potential risk of improper administration of the drug product.

Chemistry, Manufacturing and Control- The FDA has completed inspections of A.P. Pharma and several of its contract manufacturing facilities. The Agency identified certain deficiencies during these inspections, and satisfactory resolution of these deficiencies will be required for approval.- During the NDA review, the FDA asked that the Company determine if terminal sterilization with gamma irradiation is a feasible approach to enhance the assurance of sterility. A.P. Pharma has subsequently demonstrated that terminal sterilization is feasible, and the FDA has requested the Company change to terminal sterilization prior to approval.-- The FDA requested clarification and revision of certain analytical specifications proposed in the Company's NDA.....................&more.