Navigation Links
District Court Upholds FDA's Grant of 5-Year Market Exclusivity to VYVANSE(R)
Date:3/4/2010

o 5-year market exclusivity. The FDA therefore appropriately refused to file the Abbreviated New Drug Application ("ANDA") submitted by Actavis Elizabeth, LLC for generic lisdexamfetamine dimesylate. On February 24, 2009, Actavis sued the FDA in the District Court of the District of Columbia challenging the NCE decision. On April 13, 2009, the FDA opened a public docket to consider Actavis's challenge to the FDA's regulations governing NCE exclusivity and the corresponding award of exclusivity to VYVANSE. On October 23, 2009, following a thorough administrative review, the agency affirmed lisdexamfetamine, the active ingredient in VYVANSE, is a new active moiety and that its prior designation of VYVANSE as an NCE was proper.

Shire is pleased that on March 4, 2010, following the extensive briefing of the parties and an oral hearing, the Court upheld the FDA's decision (and reaffirmation) that VYVANSE is entitled to 5-year market exclusivity. The Court correctly determined that FDA's actions complied with federal administrative law standards as a reasonable exercise of the agency's scientific expertise. The five-year exclusivity period for VYVANSE expires on February 23, 2012, and precludes generic manufacturers from submitting an ANDA to FDA until that time, or until February 23, 2011 should a generic applicant challenge the United States patents covering Vyvanse, which remain in effect until June 29, 2023.


'/>"/>
SOURCE Shire plc
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related biology technology :

1. US District Court Enters Final Judgment in Favor of Smith & Nephew; Permanent Injunction Prohibits Arthrex Inc. From Selling Infringing Medical Devices
2. District Court Sides with Smith & Nephew; Rules that It will Issue Injunction that will Prohibit Arthrex Inc. from Selling Infringing Medical Devices
3. District Judge Dismisses Shareholder Suit Related to Boston Scientific
4. Ventria Receives Friends of Education Award From Geary County School District
5. U.S. District Court Decision About Eisais Legal Action Over Aricept ODT(R) ANDA Filing
6. YM BIOSCIENCES OFFER FOR CYTOPIA APPROVED TO PROCEED TO SHAREHOLDER VOTE BY AUSTRALIAN COURT
7. deCODE genetics, Inc. Announces Approval of First Day Motions by Bankruptcy Court
8. Ironwood Appoints Thomas McCourt As Chief Commercial Officer and Senior Vice President of Marketing and Sales
9. Isolagen, Inc. Announces Receipt of Interim Order from Bankruptcy Court Approving DIP Motion
10. Hospira Receives Favorable Court Decision on Eloxatin(R)
11. The Court Supports Bavarian Nordics Decision to Start Patent Infringement Case Against Oxford BioMedica
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/3/2015)... , Aug. 3, 2015  ArroGen Group, an ... new Fingerprint Molecular Identification™ (FMID) technology Aug. 2-8 ... in Sacramento, Calif. ... will enable law enforcement agents, district attorneys and ... criminal suspects. By analyzing chemical residues ...
(Date:8/3/2015)... , ... August 03, 2015 , ... Nine field days ... Illinois and Indiana. Hosted by the Soil Health Partnership , the field days ... environmental benefits while potentially increasing farm productivity and income. , Brent Bible has practiced ...
(Date:8/3/2015)... - RepliCel Life Sciences Inc. (TSX.V: RP) (OTCQB: REPCF), a ... autologous cell therapies, announced today that RepliCel,s CEO, David ... in Minneapolis, Minnesota on August 5 ... highlight RepliCel,s 18-month milestones including CE Mark for its RCI-02 ... clinical data from both RCT-01 (tendon) and RCS-01 (skin) clinical ...
(Date:7/31/2015)... ... July 31, 2015 , ... R-Biopharm is proud ... partially hydrolyzed gluten in foods, has been accepted by AOAC International as Official ... Gluten in Fermented Cereal-Based Products by R5 Competitive ELISA,” based on a specific ...
Breaking Biology Technology:ArroGen Previews New Fingerprint Molecular Identification Technology 2Soil Health Field Days Kick Off Throughout Midwest 2Soil Health Field Days Kick Off Throughout Midwest 3RepliCel Presenting at InvestMNT Investor Conference in Minneapolis 2RIDASCREEN® Competitve Gliadin Receives AOAC Official First Action Status 2
... Corporation (Nasdaq: ROCM ) will announce quarterly results ... Company will then,hold a quarterly conference call to discuss ... central daylight time (5:00 p.m. eastern time)., This ... accessed at,Rochester Medical,s website at http://www.rocm.com . To ...
... American Oriental,Bioengineering, Inc. (NYSE: AOB ) today ... results on Monday, August 11, 2008, after the,market closes., ... 5:00 pm ET on August 11,2008 to discuss its ... by dialing 1-800-599-9816 or 1-617-847-8705 for,international callers, access code: ...
... Radiofrequency ... Surgical Technologies -, PALO ALTO, Calif., July 24 ... new tissue dissection system,based on a proprietary technology, today announced that ... to market its,PEAK(R) Surgery System for use in general surgery. The ...
Cached Biology Technology:Rochester Medical Announces Third Quarter 2008 Earnings Conference Call July 31, 2008 2PEAK Surgical Receives 510(k) Clearance to Market PEAK(R) Surgery System for Use in General Surgery 2PEAK Surgical Receives 510(k) Clearance to Market PEAK(R) Surgery System for Use in General Surgery 3PEAK Surgical Receives 510(k) Clearance to Market PEAK(R) Surgery System for Use in General Surgery 4
(Date:8/3/2015)... 3, 2015 Synaptics, Inc. (Nasdaq: SYNA ... announced that members of the executive management team will ... Global Technology Leadership Forum on Tuesday, August 11, 2015 ... held at the Sonnenalp Resort in Vail, ... include forward-looking information. An audio webcast of the event ...
(Date:7/31/2015)... , Kina, 31. juli 2015 Den 10. ... afholdt af BGI fra den 22. - 25. oktober i ... Konferencen fejrer sin 10-års fødselsdag i år. Siden starten ... indflydelsesrige årlige møder på ,omik,-feltet, og er en af ... ICG-10 fokuserer på nylige gennembrud og fremskridt ...
(Date:7/31/2015)... , 31 de julio de 2015 BGI llevará ... www.icg-10.org ) del 22 al 25 de octubre de ... La conferencia celebra su décimo aniversario este año. ... en una de las reuniones anuales más influyentes del ... una de las conferencias científicas más dinámicas, entusiastas y ...
Breaking Biology News(10 mins):Den 10. internationale konference om Genomics (ICG-10) åbner i oktober 2La 10ª Conferencia Internacional sobre Genómica (ICG-10) comienza en octubre 2La 10ª Conferencia Internacional sobre Genómica (ICG-10) comienza en octubre 3
... of reduced snowfall in mountains is causing powerful and ... increased ability of elk to stay at high elevations over ... Nature Climate Change . , The U.S. Geological ... the abundance of deciduous trees and their associated songbirds in ...
... new study by Rice University,s Baker Institute for Public Policy ... young investigators and a novel standard by which to judge ... age of biomedical researchers getting their first grant from the ... the past 30 years, the average age of Nobel winners ...
... fever, dengue fever, and chikungunya fever spread rapidly around the ... mosquito,s immune system and how the viral pathogens that cause ... to human and animal hosts. In nearly every ... of morbidity and mortality after being bitten by mosquitoes infected ...
Cached Biology News:Dramatic links found between climate change, elk, plants, and birds 2Nobel history illustrates gap in grants to young scientists 2Nobel history illustrates gap in grants to young scientists 3Researchers discover novel anti-viral immune pathway in the mosquito 2
Component in MasterPure™ Purification Kits...
Anti-gp340 Monoclonal Antibody Description: 100 g Research Focus: cancer & cell proliferation Storage: -20C Shipping Temperature: 4C...
Mouse anti-HIV-Imn PND Class: Antibody Product Group: Bacterial and Viral Antigen...
... BRF2 Immunogen Synthetic peptide: QAARQAATSVPNPP, corresponding ... BRF2. Reactivity / Specificity Cross-reacts with ... Background Information BRF2 is one of the ... factor complex required for transcription of genes with ...
Biology Products: