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Executive Summary

TO USE OPTICAL DISKS FOR TWO NDA filings via an agreement with Laser Recording Systems. The agreement calls for "the full integration of Upjohn's CANDAR [computer-assisted NDA review] system and software with Laser Recording Systems' image handling software and state-of-the-art optical image hardware so that FDA reviewers can electronically view or print copies of case report forms as they review the submitted data files," Laser Recording Systems said in an Oct. 7 announcement. Upjohn has not disclosed what drugs the company has pending in an CANDA format. The company noted that it has filed two CANDAs, one for an agent in the infectious diseases area and the other for a neuropharmacologic drug. Upjohn has a second-generation cephalosporin Zefazone (cefmetazole sodium) that has been close to NDA filing stage for a year and two anxiolytic products Deracyn (adinazolam mesylate) and Unakalm (ketazolam) that have NDA's pending at FDA. Upjohn has provided FDA with five personal computers Compaq 386-320 for the review of the two CANDAs that the company submitted during the first half of 1988. The optical disk NDAs will be incorporated into the Compaq CANDA system making a single integrated workstation with one keyboard and two separate monitors, Laser Recording Systems said. One monitor will display the data contained in the CANDA, while the other monitor displays images from the optical disk NDA. This system provides the FDA reviewer "total and easy access to not only the electronic data provided by Upjohn's CANDAR system, but also to all related case report forms," Laser Recording Systems noted. Laser Recording Systems has developed an optical disk NDA for Marion's Cardizem I.V. for treating arrhythmias ("The Pink Sheet" June 27, 1988, p. 5). Marion has not yet submitted the Cardizem I.V. optical disk NDA. The company did, however, file an optical disk NDA for supplemental labeling for Cardizem tablets in July. That supplemental served as a trial run for the optical disk NDA system, Marion said. ICI Pharmaceuticals has an optical disk NDA pending for its congestive heart failure agent Carwin (xamoterol). ICI developed the optical disk NDA technology for Carwin in-house. Laser Recording Systems maintains that a major advantage of the optical disk NDA is that the reviewer can see the original documents that are referred to in the CANDA. Other features of the optical disk NDA include: a text search facility, a table of contents search facility, a key word search facility, an electronic mail facility, and a transfer facility that allows sponsors to submit amendments,, add additional information and documents to the NDA. A single optical disk has the capacity to hold over 100,000 NDA pages, Laser Recording Systems said.

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