Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

TO USE OPTICAL DISKS FOR TWO NDA

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.

You may also be interested in...



Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth

Latest Headlines
See All
UsernamePublicRestriction

Register

PS014462

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel