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Executive Summary

ANTIBIOTIC SUPPLEMENT REVIEW MOVED TO FDA ANTI-INFECTIVES DIVISION from the Division of Generic Drugs Antibiotic Review Branch, the agency notified NDA holders in a recent letter. The letter tells companies that agency officials from the Office of Generic Drugs and the Office of Drug Evaluation II agreed Sept. 4 that "full responsibility for all supplements, annual reports, and other correspondence directed to approved NDAs in the 50,000 series (innovator antibiotics) would transfer to the Division of Anti-Infective Drug Products from the Antibiotic Review Branch, Division of Generic Drugs." The transfer of responsibilities, which the Generics Division inherited from the days of the Office of Marketed Drugs, is being made in anticipation of the physical relocation of the Office of Generic Drugs this fall. That move to FDA's Metro Park North campus is scheduled for Oct. 6. The agency said that it is sending the letter to inform NDA holders of the decision "so that future communications can be directed to the appropriate division, as well as to alert [them] to the prospect that [they] will be dealing with a new group of CDER staff on post-approval matters." Submissions currently under review will be completed by the Division of Generic Drugs. Filings not yet under review will be transferred to the Anti-Infective Division. Therefore, applicants can expect "appropriate communications from either or both of the respective groups during this transition," FDA said. Generic copies of innovator products will continue to be the responsibility of the Generics Division. All antibiotic applications should be sent to Food and Drug Administration, CDER -- HFD-520, Attention: Document Control Room 12B-30, 5600 Fishers Lane, Rockville, Maryland, 20857, FDA said. Questions regarding the change should be directed to the Project Management Staff of the Division of Anti-Infective Drug Products at (301) 443-6797. FDA also issued a policy and procedure guide on generic antibiotic applications that reference unapproved bulk antibiotics. Issued Sept. 11, the guide states that in the event an application for a dosage form antibiotic reaches a certain stage of completion without prior approval of the referenced bulk antibiotic, the agency will issue a non-approvable letter asking the company to submit an amendment to the application once it has been notified of approval of the bulk product. AADA's will be located in the work queue according to the date of submission, as specified under the division's "first in-first reviewed" policy. The issuance of a non-approvable letter, however, will allow generic reviewers to take the application off of their immediate work list. Although FDA said it will continue the policy of accepting AADAs for drugs referencing unapproved, but under review, bulk antibiotics, the agency warned that "AADA applicants are taking a considerable risk if they base their applications upon unapproved antibiotic." According to the agency, if the bulk product is not approved, the applicants may be required to submit a new application with new supporting data. If the bulk antibiotic application requires significant changes, new bioequivalence and stability data may have to be generated, FDA said. FDA said it is not responsible for informing dosage form antibiotic applicants of bulk product approvals.

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