Navigation Links
Barr Receives Approval for Generic Version of Razadyne(R) ER Capsules
Date:9/16/2008

MONTVALE, N.J., Sept. 16 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. (NYSE: BRL) today announced that its subsidiary, Barr Laboratories, Inc., received final approval from the U.S. Food & Drug Administration (FDA) to manufacture and market a generic version of Ortho McNeil Janssen's Razadyne(R) ER (galantamine hydrobromide extended release capsules), eq. to 8 mg, 16 mg and 24 mg. Barr also announced that it is the first company to file an Abbreviated New Drug Application (ANDA) with the U.S. Food & Drug Administration (FDA) containing a Paragraph IV certification for a generic version of Razadyne ER capsules, and therefore is entitled to 180-days of marketing exclusivity, as provided for under the Hatch Waxman Act. The Company intends to launch its product shortly.

Barr filed its ANDA with the FDA containing a Paragraph IV certification for the 8 mg eq. capsule strength of Razadyne ER on March 1, 2006. Barr amended its ANDA on March 10, 2006 to include the 16 mg eq. and 24 mg eq. capsule strengths in its filing. Following receipt of the notice from the FDA that Barr's ANDA was accepted for filing, Barr notified the New Drug Application (NDA) holder and patent owner.

On July 6, 2006, Barr announced that Janssen had filed suit against the Company in the U.S. District Court of New Jersey asserting U.S. Patent No. 4,663,318 ("the '318 patent") against Barr. Barr subsequently amended its application to certify that a later listed patent, U.S. Patent No. 7,160,559 ("the '559 patent"), which was not listed at the time Barr's original ANDA was filed, was invalid, unenforceable or not infringed, and provided notice of this to Janssen. Janssen subsequently filed a new suit asserting the '559 patent against Barr.

On Augu
'/>"/>

SOURCE Barr Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related biology technology :

1. Intact Medical Corporations Intact(R) Excise XL Receives 510(K) Marketing Clearance from the FDA
2. Cardica Receives $1 Million Milestone Payment From Cook Medical for Development of Heart Defect Closure Device
3. CTI Receives NASDAQ Letter
4. BioMS Medicals lead drug, dirucotide (MBP8298) for the treatment of multiple sclerosis, receives fast track designation from FDA
5. Repligen Receives Research Grants to Support Friedreichs Ataxia Development Program
6. ESA Receives 2008 Frost & Sullivan North American Technology Innovation Award for Development of Integrated Metabolomics Systems
7. Moffitt Cancer Center Receives Prestigious SPORE Grant Worth More Than $10 Million
8. Barr Receives Approval for Generic Version of Razadyne(R) Tablets
9. Instrumentation Laboratory Receives FDA Clearance to Expand the Intended Use of HemosIL(R) D-Dimer Assay
10. Gleevec Receives FDA Priority Review as First Therapy to Reduce Recurrence of Gastrointestinal Stromal Tumors After Surgery
11. TorreyPines Therapeutics Receives NASDAQ Deficiency Notice
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/19/2014)... Jose, California (PRWEB) September 19, 2014 ... Nanotechnology and its potential to revolutionize the world ... agencies, multinational corporations and small start-ups. The early ... funded research projects largely due to the high ... investments. Government budgets earmarked for this evolving technology ...
(Date:9/19/2014)... , Sept. 19, 2014 Pfenex Inc. ... the development of high-value and difficult to manufacture proteins ... presenting at the 21 st Annual NewsMakers in ... . Bertrand Liang , chief executive officer ... development programs and business strategy on Friday, September 26, ...
(Date:9/19/2014)... -- Dublin ... the addition of the  "Micro Market Monitor : ...      (Logo: http://photos.prnewswire.com/prnh/20130307/600769) , , ,The ... segments in the chromatography market. The market was ... to reach $2.0 billion by 2019, at a ...
(Date:9/18/2014)... 18, 2014 HealthTronics, Inc ... interventional radiology products and services, announced that a ... and cryoablation) versus external beam radiotherapy (EBRT) is ... American Urological Association (MAAUA) Annual Meeting in Baltimore, ... Effectiveness of Cryosurgery and External Beam Radiation as ...
Breaking Biology Technology:Growing R&D Investments & Developments in Nanomaterials to Drive the Global Nanotechnology Market, According to New Report by Global Industry Analysts, Inc. 2Growing R&D Investments & Developments in Nanomaterials to Drive the Global Nanotechnology Market, According to New Report by Global Industry Analysts, Inc. 3Growing R&D Investments & Developments in Nanomaterials to Drive the Global Nanotechnology Market, According to New Report by Global Industry Analysts, Inc. 4Pfenex to Present at Upcoming Industry Conference on September 26 2Micro Market Monitor : Global Pre-packed Chromatography Columns 2HealthTronics Announces Data Comparing Cryotherapy Versus Radiation for Treating Prostate Cancer Poster Presented at the American Urological Association Regional Meeting 2
... ORLEANS , May 3 The American ... American Gastroenterological Association (AGA)Institute today announced an innovative ... ," at Digestive Disease Week ® 2010.  The peer-driven ... front lines of the diagnosis and treatment of hereditary ...
... , May 3, 2010 PolyTouch Medical Ltd., a,leading ... filed a Premarket 510(k) Application with the US Food,and Drug Administration ... accurate mesh placement in,laparoscopic ventral hernia repair potentially reducing procedure time ... ...
... ... In a bid to develop new feedstocks with greater sustainability and ... to meet the growing demand, of biodiesel CJP’s R & D centre ... biodiesel crops and has identified, developed and cultivated as many as 14 ...
Cached Biology Technology:ACAAI and AGA Partner to Raise Awareness of Hereditary Angioedema Through 'HAE: Learn About It, Talk About It' 2ACAAI and AGA Partner to Raise Awareness of Hereditary Angioedema Through 'HAE: Learn About It, Talk About It' 3ACAAI and AGA Partner to Raise Awareness of Hereditary Angioedema Through 'HAE: Learn About It, Talk About It' 4ACAAI and AGA Partner to Raise Awareness of Hereditary Angioedema Through 'HAE: Learn About It, Talk About It' 5PolyTouch Medical Ltd. Announces the Submission of a Premarket Application for PatchAssist - an Innovative Mesh Deployment and Placement Device for Laparoscopic Hernia Repair 2PolyTouch Medical Ltd. Announces the Submission of a Premarket Application for PatchAssist - an Innovative Mesh Deployment and Placement Device for Laparoscopic Hernia Repair 3CJP Assesses Pongamia, Moringa, Castor, Simarouba, Algae etc. as New Sustainable Biodiesel Crops 2CJP Assesses Pongamia, Moringa, Castor, Simarouba, Algae etc. as New Sustainable Biodiesel Crops 3CJP Assesses Pongamia, Moringa, Castor, Simarouba, Algae etc. as New Sustainable Biodiesel Crops 4
(Date:9/18/2014)... Sydney, September 18, 2014 Elsevier, a world-leading ... and services, and the Australasian Research Management Society ... young scientists at the 5th Scopus Young Researcher ... held earlier today at the National Convention Centre ... conference, was attended by guests representing Australia,s and ...
(Date:9/18/2014)... to 400 kilometres in search of a home, which makes ... spend their entire adult lives under the protection of their ... ocean, says study co-author, Dr Hugo Harrison from the ARC ... James Cook University. , "In the past we haven,t known ... glimpse into how far they can swim, crossing large tracts ...
(Date:9/17/2014)... has received a $260,000 grant from the Andrew W. ... the Human in the Age of the Life Sciences." ... events aimed at exploring two compelling themes in the ... are exploring the boundaries of our self-definition as a ... involves the increasingly influential hypothesis that we are living ...
Breaking Biology News(10 mins):Elsevier and Australasian Research Management Society award scientists at Scopus ceremony 2Nemo's epic journey to find a new home 2Mellon Foundation awards grant for major project in the humanities and sciences 2
... female of its species can extend the reproductive life of a ... reported at the online site of the journal Biology of ... the University of Pennsylvania School of Veterinary Medicine, male mice were ... Each male was placed with two novel females at 2-month intervals ...
... NY, January 22, 2009--Biotechnology companies are building on ... the past decade and are expected to drive ... reports Genetic Engineering and Biotechnology News ... offers a number of advantages, including reducing reagent ...
... in the journal Nature , researchers led by ... in the Kimmel Cancer Center at Jefferson, discovered a ... AIM2 (absent in melanoma 2), is involved in the ... produced by infection with viral or microbial pathogens, or ...
Cached Biology News:GEN reports on growing reliance on microfluidics technology 2Jefferson scientists discover a key protein regulator of inflammation and cell death 2
Monoclonal Anti-Cystatin A tissue culture supernatant Solution containing 15 mM sodium azide human cystatin A ...
... Series are a line of pre-integrated ... fast and reliable automated solutions to ... "automation-friendly" building blocks, Caliper has created ... than conventional approaches, take up little ...
... Guava has made microcapillary flow cytometry accessible ... experts alike will appreciate the latest addition ... Pluseasy to use, surprising affordable, and very ... system includes such features as absolute cell ...
... Rotator, variable speed, timer, SB3, Fully ... Choice of tube holders to hold a ... The SB3 is ideal for aerating cultures, ... general mixing applications., The rotator can be ...
Biology Products: