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Executive Summary

"NDA DAY" PLANNED FOR NOVEL DOSAGE FORM OF PREVIOUSLY APPROVED ingredient, FDA Pilot Drug Review Division consumer safety officer James Hannan told a May 14 conference in Washington, D.C. Reporting on the continued use of "NDA Days" as an overview to bring together the final stages of application review, Hannan told the "1990 NDA Pipeline Conference" that his division is beginning to schedule the next of the sponsor/agency meetings for July. FDA typically sets a firm date for an "NDA Day" about three weeks prior to the event. Alza's fentanyl patch product is a logical candidate for the July "NDA Day" based on the status of that application, Hannan's description of "novel dosage" form to be reviewed, and the purview of the Pilot Drug Division at FDA. As a narcotic analgesic, the active ingredient is being reviewed by the analgesic drug review group. The patch dosage form has been pending at FDA since the end of 1987. Alza says that the company has been informed that TTS-fentanyl will be the subject of an "NDA Day." FDA's Pilot Drug Division hopes to be able to devote more attention to final labeling review at the future "NDA Days." That has been an area that has led to delays following "NDA Day" agreements on the bulk of the approval issues. For the upcoming, July meeting, FDA hopes to have a final package insert complete by the end of the "NDA Day." TTS-fentanyl will be marketed by Janssen Pharmaceutica. The J&J subsidiary has marketed the ingredient as an injectable analgesic used in conjunction with anesthetics. Alza will have the right to co-market the product to oncologists. Alza has maintained in the past that the active ingredient shows great potential as an analgesic. When the company first described the compound to analysts several years ago, an Alza exec said fentanyl is "more than 100 times as powerful in the containment of pain as morphine." The ingredient has not been available for analgesia because it cannot be delivered orally. TTS-fentanyl is being developed for "patients experiencing acute postoperative pain or the severe, long-term pain often associated with cancer." The dosage form can deliver the ingredient for up to 72 hours. Alza has worked closely with the Pilot Drug Division at FDA. It is one of two companies that has reportedly discussed management information systems with the division for tracking NDA documents. The other company that has consulted with FDA on that effort is Wyeth-Ayerst. The "NDA Day" review process is being tested outside the Pilot Drug Division. The Oncology & Pulmonary Drug Division in the Office of Drug Evaluation I has reportedly experimented with the NDA concept.

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