Navigation Links
Barr Receives Approval for Generic Version of Razadyne(R) Tablets
Date:8/28/2008

MONTVALE, N.J., Aug. 28 /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) (galantamine hydrobromide), 4 mg, 8 mg and 12 mg tablets. Barr intends to launch its generic Razadyne tablets product immediately.

Barr filed an Abbreviated New Drug Application (ANDA) with the U.S. Food & Drug Administration (FDA) for Janssen's Razadyne (galantamine hydrobromide), 4 mg, 8 mg and 12 mg tablets on February 28, 2005, the first day that an ANDA containing a Paragraph IV certification could be submitted based on the expiration of the New Chemical Entity (NCE) exclusivity on the product. Following receipt of notification from the FDA of the application's acceptance for filing, Barr notified the New Drug Application (NDA) holder and patent owner of Barr's challenge to the patents protecting Razadyne. On June 15, 2005, Barr announced that Janssen had filed suit in the District Court for the District of Delaware, and the trial occurred in May 2007.

On June 15, 2005, Barr announced that Janssen had filed suit in the District Court of Delaware. Janssen announced in its Form 10-Q filed with the U.S. Securities & Exchange Commission on May 10, 2005 that it had received Paragraph IV certifications for Razadyne from six other generic pharmaceutical companies relating to the patents protecting Razadyne.

Earlier today, Barr announced that the U.S. District Court for the District of Delaware has ruled in favor of its subsidiary, Barr Laboratories, Inc., in the challenge of U.S. Patent No. 4,663,318 ("the '318 patent") li
'/>"/>

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

Page: 1 2 3 4 5

Related biology technology :

1. Instrumentation Laboratory Receives FDA Clearance to Expand the Intended Use of HemosIL(R) D-Dimer Assay
2. Gleevec Receives FDA Priority Review as First Therapy to Reduce Recurrence of Gastrointestinal Stromal Tumors After Surgery
3. TorreyPines Therapeutics Receives NASDAQ Deficiency Notice
4. Omaxe Infrastructure & Construction Private Ltd Receives LoI for Construction of Allopathic Medical College and Associated Hospital at Saharanpur, UP With Construction Value of Approx 250 Crores
5. Caliper Life Sciences Receives $1.1 Million Task Order from the EPAs ToxCast(TM) Screening Program
6. Biotest Diagnostics Receives FDA Clearance for Full Line of Traditional Blood Bank Reagents
7. BMP Sunstone Receives Production License from the SFDA to Manufacture and Market Pediatric Multivitamin Granules in the PRC
8. XTL Biopharmaceuticals Receives Notice of Non-Compliance with Nasdaq Marketplace Rule Due to Changes in Board Composition
9. CV Therapeutics Receives European Approval for the Brand Name Ranexa(R)
10. SGX - Lilly Merger Offer Receives Positive Opinions From Proxy Advisory Firms
11. Angiotech receives CE Mark approval of HemoStream(TM) Chronic Dialysis Catheter
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/2/2015)... Sept. 2, 2015 Axovant Sciences Ltd. (NYSE:  AXON), ... dementia, today announced upcoming presentations at three investor conferences: ... Baird 2015 Healthcare Conference in New York ... September 10 at 2:00 PM at the BioCentury NewsMakers Conference ... Broadway Hotel & Conference Center , Thursday, September 17 ...
(Date:9/2/2015)... Sept. 2, 2015 Research and ... addition of Jain PharmaBiotech,s new report ... their offering. An increasing ... biotechnology industries is anticipated. Nanotechnology will be ... - from formulations for optimal delivery to ...
(Date:9/2/2015)... ANN ARBOR, Mich. and LIBERTYVILLE, Ill. (PRWEB) , ... ... ... NSF International, a leading provider of regulatory compliance, quality systems, ... acquired Avarent LLC, a consulting firm with expertise in medical device products/processes ...
(Date:9/2/2015)... 02, 2015 Research ... addition of Jain PharmaBiotech,s new report "DNA ... their offering. This report briefly reviews ... technologies, and their applications. Current large and small ... them. Various applications of sequencing are described including ...
Breaking Biology Technology:Axovant Sciences To Present At Upcoming Investor Conferences 2Axovant Sciences To Present At Upcoming Investor Conferences 3Global Nanobiotechnology Applications, Markets and Companies Report 2015-2024 2Global Nanobiotechnology Applications, Markets and Companies Report 2015-2024 3NSF International Strengthens Medical Device Consulting With Acquisition of Avarent LLC 2NSF International Strengthens Medical Device Consulting With Acquisition of Avarent LLC 3NSF International Strengthens Medical Device Consulting With Acquisition of Avarent LLC 4NSF International Strengthens Medical Device Consulting With Acquisition of Avarent LLC 5NSF International Strengthens Medical Device Consulting With Acquisition of Avarent LLC 6NSF International Strengthens Medical Device Consulting With Acquisition of Avarent LLC 7Global DNA Sequencing Technologies Report 2015: Profiles of 130 Companies Involved in Sequencing and their 140 Collaborations 2
... SAN DIEGO, Sept. 16 TriLink BioTechnologies, Inc. (TriLink), ... discontinued the service in May 2009 after ordering trends in ... However, strong customer feedback led TriLink to bring back its ... "We,ve learned that no other suppliers have exactly our expertise ...
... NEW HAVEN, Conn., Sept. 16 Rib-X Pharmaceuticals, ... of novel drugs for the treatment of multi-antibiotic resistant infections, ... Company,s Board of Directors, succeeding Joseph Amprey, MD, Ph.D. ... MedImmune, Chief Executive Officer of AstraZeneca North America, and Executive ...
... , , PHILADELPHIA, Sept. ... for biomedical research, molecular diagnostics and personalized medicine, today announced ... joined the company,s advisory team. Dr. Lee is a ... Brigham and Women,s Hospital, Harvard Medical School and the Broad ...
Cached Biology Technology:TriLink BioTechnologies, Inc. Relaunches Oligonucleotide Radiolabeling Services 2Rib-X Pharmaceuticals, Inc. Appoints Tony Zook of MedImmune to Board of Directors 2Rib-X Pharmaceuticals, Inc. Appoints Tony Zook of MedImmune to Board of Directors 3BioNanomatrix Appoints Genomic Research Experts Charles Lee and David L. Barker as Advisers 2BioNanomatrix Appoints Genomic Research Experts Charles Lee and David L. Barker as Advisers 3BioNanomatrix Appoints Genomic Research Experts Charles Lee and David L. Barker as Advisers 4
(Date:8/20/2015)... 2015 NXT-ID, Inc. (NASDAQ: NXTD ) ... on the growing mobile commerce market and creator of ... Smart Card Alliance and the EMV Migration Forum.  ... Smart Card Alliance Latin America (SCALA) Chapter provides NXT-ID, ... thought leaders promoting adoption of smart card technology. ...
(Date:8/17/2015)... Conn. , Aug. 17, 2015  NXT-ID, Inc. ... biometric authentication company focused on the growing mobile commerce ... its new sales campaign for Q4 2015. The new ... marketing team consisting of Amplitude Marketing Group ( http://amplitudemarketing.com/ ... Marketing Group is a leader in retail driven marketing ...
(Date:8/12/2015)... 2015  Synaptics Inc. (NASDAQ: SYNA ), ... announced that four of its fingerprint ID products, ... been named FIDO Certified™ by the Fast IDentity ... Synaptics, Natural ID™ fingerprint solutions are fully compliant ... standard and are interoperable among other products and ...
Breaking Biology News(10 mins):NXT-ID, Inc. Joins Smart Card Alliance and EMV Migration Forum 2NXT-ID, Inc. Joins Smart Card Alliance and EMV Migration Forum 3NXT-ID, Inc. Joins Smart Card Alliance and EMV Migration Forum 4NXT-ID, Inc. Launches Sales Campaign for Wocket Smart Wallet with Award Winning Marketing Team 2NXT-ID, Inc. Launches Sales Campaign for Wocket Smart Wallet with Award Winning Marketing Team 3Synaptics Announces FIDO Certification of Natural ID Fingerprint Solutions 2Synaptics Announces FIDO Certification of Natural ID Fingerprint Solutions 3
... With its deeply embedded roots, sturdy trunk and dense ... structure of nearly unfathomable complexity and beauty. While major ... encompassing every living species, the project is still ... Biodesign Institute, Sudhir Kumar has been filling in the ...
... California, Davis, plant scientist has identified a source of carbon emissions ... change. While earlier studies have found that erosion can bury ... the new study published this week in the journal Proceedings ... that sink is only temporary. "It,s all part of figuring ...
... study show that episodes of reduced precipitation in the Southern ... rise in numbers of mountain pine beetles. The overabundance is ... first to chart the evolution of the current pine beetle ... of beetle outbreaks in the two primary host species, the ...
Cached Biology News:A new computational method for timing the tree of life 2A new computational method for timing the tree of life 3Carbon buried in the soil rises again 2Drought in 2001-2002 fueled Rocky Mountain pine beetle outbreak 2Drought in 2001-2002 fueled Rocky Mountain pine beetle outbreak 3Drought in 2001-2002 fueled Rocky Mountain pine beetle outbreak 4
... DeCypher combines enterprise-scale sequence analysis software with ... bioinformatics analyses. With DeCypher, you can perform searches ... ESTs vs NCBI NT database in under 6 ... to genomic DNA Use HMM analysis ...
...
Mouse polyclonal antibody to ALS2CR8 - amyotrophic lateral sclerosis 2 (juvenile) chromosome region, candidate 8...
...
Biology Products: