Printer Friendly
The Free Library
19,585,946 articles and books
Member login
User name  
Password 
 
Join us Forgot password?

Allergan Receives Positive Opinions for COMBIGAN(TM) from 21 Countries in European Union.


IRVINE, Calif. -- Allergan, Inc. (NYSE NYSE

See: New York Stock Exchange
:AGN AGN Again (Amateur Radio)
AGN Active Galactic Nucleus
AGN Acute Glomerulonephritis
AGN Accountants Global Network
AGN Air Gabon (ICAO code) 
) today announced that it received positive opinions for COMBIGAN(TM), Allergan's ALPHAGAN(R)/timolol combination product for glaucoma (brimonidine tartrate/timolol ophthalmic solution ophthalmic solution
n.
A sterile solution that is free from foreign particles and is compounded and dispensed for eyedrops.
), from all twenty-one Concerned Member States included in the COMBIGAN(TM) Mutual Recognition Procedure (MRP (Material Requirements Planning) An information system that determines what assemblies must be built and what materials must be procured in order to build a unit of equipment by a certain date. ) for the European Union European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the

European Community
. Allergan received notification of the positive opinions for COMBIGAN(TM) from the Medicines and Healthcare products Regulatory Agency The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK government agency which is responsible for ensuring that medicines and medical devices work and are acceptably safe.  (MHRA MHRA Medicines and Healthcare Products Regulatory Agency
MHRA Modern Humanities Research Association (United Kingdom)
MHRA Minnesota Human Rights Act
MHRA Malta Hotels and Restaurants Association
) in the United Kingdom, which acted as the Reference Member State for the MRP. Marketing authorization and national licenses for COMBIGAN(TM) are expected to be issued in the coming months following each country's assessment of the local product labeling making COMBIGAN(TM) available in all countries of the European Union.

COMBIGAN(TM) is indicated for reduction of intraocular pressure intraocular pressure
n.
The pressure of the intraocular fluid within the eye.


intraocular pressure (in´tr
 (IOP IOP

intraocular pressure.

IOP Intraocular pressure, see there
) in patients with chronic open-angle glaucoma o·pen-an·gle glaucoma
n.
Primary glaucoma in which the aqueous humor has free access to the trabecular reticulum. Also called simple glaucoma.
 or ocular hypertension who are insufficiently responsive to topical beta-blockers.

"We are extremely pleased by the successful conclusion of the mutual recognition procedure for COMBIGAN(TM), which allows us to make this valuable medicine available to glaucoma patients throughout the European Union," said Dr. Scott Whitcup, Allergan's Executive Vice President, Research & Development.

About Allergan, Inc.

Allergan, Inc., with headquarters in Irvine, California, is a technology-driven, global health care company providing specialty pharmaceutical products worldwide. Allergan develops and commercializes products in the eye care, neuromodulator, skin care and other specialty markets that deliver value to its customers, satisfy unmet medical needs, and improve patients' lives.

Forward-Looking Statements

This press release contains "forward-looking statements," including, among other statements, the statements by Dr. Whitcup, statements regarding research and development outcomes, efficacy, and market and product potential. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Allergan's expectations and projections. Risks and uncertainties include general industry and pharmaceutical market conditions; general domestic and international economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents obtained by competitors; challenges inherent in product marketing such as the unpredictability of market acceptance for new pharmaceutical and biologic products and/or the acceptance of new indications for such products; domestic and foreign health care reforms; the timing and uncertainty of the research and development and regulatory processes; trends toward managed care and health care cost containment; and governmental laws and regulations affecting domestic and foreign operations. Allergan expressly disclaims any intent or obligation to update these forward-looking statements except as required to do so by law.

Additional information concerning these and other risk factors can be found in press releases issued by Allergan, as well as Allergan's public periodic filings with the Securities and Exchange Commission, including the discussion under the heading "Certain Factors and Trends Affecting Allergan and its Businesses" in Allergan's 2004 Form 10-K and Allergan's Form 10-Q for the quarter ended June 24, 2005. Copies of Allergan's press releases and additional information about Allergan is available on the World Wide Web at www.allergan.com or you can contact the Allergan Investor Relations Department by calling 1-714-246-4636.
COPYRIGHT 2005 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2005, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

 Reader Opinion

Title:

Comment:



 

Article Details
Printer friendly Cite/link Email Feedback
Publication:Business Wire
Geographic Code:1USA
Date:Sep 28, 2005
Words:509
Previous Article:ESPRE Solutions, Inc. (EPRT) Receives $15 Million Strategic Investment from Joint Venture Partner StreamTraX Visual Communication Technologies, Inc.
Next Article:PMI Announces Appointments of Head of Sales and Market Development for Europe and Sales Manager for Italy.
Topics:



Related Articles
ALLERGAN LICENSES QUINOLONE ANTIBIOTIC FROM KYORIN.
Pyott's Voyage in Lilliput.
CPMP RECOMMENDS MARKETING AUTHORIZATION FOR KINERET.
FDI down in IQ02. (New Business).
LILLY'S TERIPARATIDE GETS POSITIVE OPINION FROM EUROPEAN CPMP.
Allergan Reports First Quarter Operating Results and Increases Full Year Earnings Guidance.
Allergan Reports Third Quarter Operating Results and Increases Full Year Earnings Guidance; Pharmaceutical Sales Increased 25 Percent for the Third...
Allergan Announces FDA Issues Approvable Letter for COMBIGAN(TM) (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%.
CHMP ADOPTS POSITIVE OPINION FOR ALEXION'S SOLIRIS IN EUROPE.

Terms of use | Copyright © 2012 Farlex, Inc. | Feedback | For webmasters | Submit articles