Printer Friendly

JUDGE DENIES BARR SHUTDOWN

 POMONA, N.Y., Feb. 5 /PRNewswire/ -- Judge Alfred M. Wolin of Federal District Court in Newark, N.J., yesterday denied the FDA's request to shutdown Barr Laboratories (AMEX: BRL).
 The judge has ordered the temporary suspension of 24 products in Barr's current product line. Because Barr cannot forecast how long the products will be unavailable, it is difficult to assess the full financial impact of the temporary suspensions. These products on a full-year basis represent approximately 40 percent of the company's sales. Well before this opinion was issued, Barr had initiated many of the validation studies the judge is requesting on the temporarily suspended products.
 Barr will continue to manufacture and ship 34 of its products.
 The judge has also ordered recalls which are limited in scope. They concern a total of 12 specific batches of 8 different products. These dozen batches are out of thousands that Barr makes every year. Half of the batches are more than two years old, and all are more than a year old.
 "...the court cannot ignore Barr's remedial efforts, as reflected in the satisfaction of many of the concerns of its experts," wrote Judge Wolin.
 According to Barr Laboratories' President Bruce Downey, "None of the judge's issues concern health and safety, but rather certain federal specifications in the manufacturing process. Our job right now is to explain the judge's decision to our customers, correct what the judge believes needs attention, and get back to a productive working relationship with the FDA."
 -0- 2/5/93
 /CONTACT: Bruce Downey, president of Barr Laboratories, 914-362-2900, or 914-362-2901/
 (BRL)


CO: Barr Laboratories ST: New York IN: MTC SU:

SH-PS -- NY001 -- 3383 02/05/93 08:46 EST
COPYRIGHT 1993 PR Newswire Association LLC
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1993 Gale, Cengage Learning. All rights reserved.

Article Details
Printer friendly Cite/link Email Feedback
Publication:PR Newswire
Date:Feb 5, 1993
Words:281
Previous Article:UNITED HEALTHCARE CORPORATION REPORTS HEALTH PLAN, SPECIALTY ENROLLMENT GAINS
Next Article:UNITED AIRLINES ASKS FOR A PUBLIC REVIEW BY DOT OF AIR CANADA'S PROPOSED $450 INVESTMENT IN CONTINENTAL AIRLINES
Topics:


Related Articles
BARR LABORATORIES PRESENTS ORAL ARGUMENTS BEFORE JUDGE REGARDING TRANSFER MOTION OF FDA ACTION
BARR LABORATORIES AND FDA MEET WITH DISTRICT COURT JUDGE WOLIN
BARR AND FDA MEET WITH DISTRICT COURT JUDGE WOLIN
BARR AND FDA RESUME NEGOTIATIONS
JUDGE CLEARS WAY FOR AZT TRIAL TO BEGIN JUNE 28
AZT CASE TO BE HEARD IN COURT OF APPEALS
Delaware Judge Rejects DuPont Motion to Dismiss Barr's Anti-Trust Case.
Barr Prozac Challenge to Proceed on Grounds of Inequitable Conduct; Company Disappointed with Judge's Decision Dismissing Additional Claims.
U.S. Court of Appeals Denies Rehearing Request in Dismissal of Tamoxifen Citrate Antitrust Lawsuits.
United States Court of Appeals denies rehearing request in dismissal of Tamoxifen Citrate antitrust lawsuits.

Terms of use | Copyright © 2016 Farlex, Inc. | Feedback | For webmasters