Printer Friendly

/FIRST ADD -- NY081 -- ELAN'S NICOTINE PATCH APPROVED BY FDA/

 /FIRST ADD -- NY081 -- ELAN'S NICOTINE PATCH APPROVED BY FDA/
 In welcoming the approval, Elan's chairman and CEO, Donald E. Panoz, stated that "Elan's unique delivery system achieved the highest level of drug utilization and the lowest residual levels of all currently approved brands of nicotine patches. Our system maintains consistent levels of nicotine throughout a 24-hour period so as to relieve the user's physical dependence on nicotine.
 "This is Elan's second New Drug Approval under its Mind-to-Market strategy where we handled the entire approval process with the agency. I am also pleased to note this very fast full approval following our NDA day, as a result of excellent collaboration with the staff of the FDA's Pilot Drug Evaluation Division."
 In a further comment regarding the marketing of ProStep, Panoz said, "I am pleased that our partner for ProStep is Lederle Laboratories whose expertise, enthusiasm, and substantial commitment of sales effort for ProStep gives our product the best opportunity of success in this exciting new market."
 Lederle Laboratories will offer ProStep users an opportunity to enroll in the ProStep Support Program, which includes motivational aids, telephone support, referral services and patient education materials.
 Extensive clinical studies carried out at the Mayo Clinic, Duke University and other prestigious medical centers in the U.S. and Europe show that the quit rate with Elan's patch was twice as effective as placebo. Quit rates in these studies were measured as total abstinence from smoking which was confirmed by carbon monoxide levels.
 In Ireland this product has been marketed as Niconil(TM) for over 18 months where it is now the most frequently used smoking cessation product.
 Elan's patented transdermal nicotine system is also being marketed in Europe and Southeast Asia. The most recent launch of the product was in Italy under the brand name Nicotrans(TM), where it is the first over- the-counter nicotine transdermal product.
 Elan Corporation, plc is a leader in the specialized health care field of advanced reformulations and drug delivery, concentrating on improved drug absorption and utilization. Elan operates research and manufacturing facilities in Athlone, Republic of Ireland; Gainesville, Ga., Enschede, Netherlands; Manila, Philippines; Brea, Calif., and Cambridge, Mass.
 -0- 1/28/92 AA NY081
 /END FIRST AND FINAL ADD/
 (ELN) CO: Elan Corporation, plc ST: IN: MTC SU: PDT


SB-JT -- NY081A -- 4361 01/28/92 15:35 EST
COPYRIGHT 1992 PR Newswire Association LLC
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1992 Gale, Cengage Learning. All rights reserved.

Article Details
Printer friendly Cite/link Email Feedback
Publication:PR Newswire
Date:Jan 28, 1992
Words:389
Previous Article:CENTURY PRODUCTS RECALLS WIND-UP INFANT SWINGS
Next Article:NORTHWEST AIRLINES HONORS SUPER BOWL VOLUNTEERS
Topics:


Related Articles
ELAN TO DOUBLE SIZE OF GAINESVILLE, GA. FACILITY FOR PRODUCTION OF NICOTINE PATCH AND OTHER DRUGS
ELAN'S SMOKING CESSATION PRODUCT -- FIRST OTC LAUNCH
PROSTEP NICOTINE TRANSDERMAL SYSTEM RECEIVES APPROVAL
U.S. FDA APPROVES ELAN'S NICOTINE PATCH
ELAN STEPS UP PROSTEP PATCH PRODUCTION FOR CYANAMID'S LEDERLE; MORE THAN FOUR MILLION SHIPPED THUS FAR
COURT RULES IN FAVOR OF CYGNUS MOTION FOR SUMMARY JUDGMENT; DISMISSES IMPORTANT PARTS OF PATENT INFRINGEMENT SUIT
ELAN ADDS $200 MILLION OF NICOTINE PATCH PRODUCTION CAPACITY WITH SECOND UNIT; U.S. MARKET SHARE NOW AT 30 PERCENT
USE OF ELAN'S PATCH DOUBLES QUIT RATE AT ONE YEAR
LEDERLE EXTENDS PROSTEP REBATE THROUGH END OF YEAR TO MAKE PRESCRIPTION NICOTINE PATCH MORE ACCESSIBLE IN LIGHT OF FDA BAN ON OVER-THE-COUNTER...
IN RESPONSE TO MEDIA INQUIRIES REGARDING THE MARKETING APPROVAL OF NICOTROL, SMITHKLINE BEECHAM ISSUED THE FOLLOWING STATEMENT:

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