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Executive Summary

PENDING PAPER NDAs MAY BE CONVERTED TO ANDAs if reviews of the pending applications are not anticipated to be completed on or about Nov. 26 or if "not approvable or deifiency letters are still outstanding," FDA Center for Drugs & Biologics Director Harry Meyer, MD, informed mfrs. in an Oct. 11 letter. Meyer explained that applicants wanting to convert a pending paper NDA should submit a request to the Office of Drug Research & Review or the Office of Biologics Research & Review to have the application transferred to the Generic Drugs Div. for processing, and after Nov. 26 submit an ANDA to the Generic Div. If the paper NDA is already in the Generic Drug Div., the agency said, the applicant should submit an amendment requesting that it be considered administratively as an ANDA on Nov. 26, the date the ANDA/patent bill provisions become effective. In addition, FDA explained that "all firms seeking to convert paper NDAs to ANDAs should submit the required patent certification and other information required by the statute" as well as a statement withdrawing the literature portion of the paper NDA. The agency noted that it will use "the initial date of submission of active paper NDAs and the dates of subsequent communications" in establishing the review priority of converted paper NDAs and resubmitted and new ANDAs. Meyer's letter gives preliminary guidance on how post-1962 ANDAs, patent and exclusivity information required by the new law should be submitted. Meyer noted that the agency is preparing additionl interim guidance, which it hopes to make available within 30 days. Under the new statute, all new paper NDAs and ANDAs, including those for DESI drugs, must include an "acceptable bioavailability/bioequivalence study or protocol (where in vivo studies are required)," the agency stated. In addition, all ANDA or paper NDA applicants must certify patent information on the subject drug. The generic sponsor must indicate either that: "(1) no patent information has been filed; (2) the patent has expired; (3) the date on which the patent will expire; or (4) the patent filed is invalid or will not be infringed by the manufacture, use, or sale of the new drug for which the application is submitted." Also under the bill, FDA said, all holders of approved NDAs are required to file with FDA the patent number and expiration date of any effective patents which claim the drug or a method of using such drug by Oct. 24. FDA noted that its Approved Rx Drug Product List and monthly supplements will include a list of all marketed drugs currently approved for safety and effectiveness and whether in vitro and/or in vivo bioequivalence studies are required for approving ANDAs of the drugs. Patent information and information on periods of exclusivity for submission or approval of ANDAs for specific products will be included in supplements to the publication. Questions about the resubmission of ANDAs should be directed to David Rosen, Div. of Generic Drugs at 301-443-4080. Patent and exclusivity information should be submitted to Thomas McGinnis, Division of Drug Information Resources, Room 8B33, HFN-84, 5600 Fishers Lane, Rockville, Md. 20857.

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