Navigation Links
Cephalon Notified of Generic Fentanyl Buccal Tablet Filing
Date:4/24/2008

FRAZER, Pa., April 24 /PRNewswire-FirstCall/ -- Cephalon, Inc., (Nasdaq: CEPH) today announced its receipt of a Paragraph IV Certification Notice Letter relating to an Abbreviated New Drug Application (ANDA) submitted to the U.S. Food and Drug Administration (FDA) by Watson Laboratories, Inc., requesting approval to market and sell a generic version of FENTORA(R) (fentanyl buccal tablet) [C-II]. In its Notice Letter, Watson alleges that the U.S. Patent Numbers 6,200,604 and 6,974,590 covering FENTORA are invalid, unenforceable and/or will not be infringed by Watson's manufacture, use or sale of the product described in its ANDA.

Cephalon currently is reviewing the Notice Letter and, by statute, has 45 days to initiate a patent infringement lawsuit against Watson. Such a lawsuit would automatically prevent the FDA from approving the Watson ANDA until the earlier of a district court decision or 30 months from the company's receipt of the Notice Letter.

Cephalon has a three-year period of marketing exclusivity for FENTORA that extends until September 2009. Additionally, the method of use patents described above expire in 2019.

About Cephalon, Inc.

Founded in 1987, Cephalon, Inc. is an international biopharmaceutical company dedicated to the discovery, development and commercialization of innovative products in four core therapeutic areas: central nervous system, pain, oncology and addiction. A member of the Fortune 1000, Cephalon currently employs approximately 3,000 people in the United States and Europe. U.S. sites include the company's headquarters in Frazer, Pennsylvania, and offices, laboratories or manufacturing facilities in West Chester, Pennsylvania, Salt Lake City, Utah, and suburban Minneapolis, Minneso
'/>"/>

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

Page: 1 2 3

Related biology technology :

1. Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain
2. Cephalon, Inc. Announces Agreement to Acquire AMRIX, A Once-Daily Extended-Release Muscle Relaxant
3. Cephalon Reinforces Important Prescribing and Dosing Information for FENTORA
4. Cephalon Submits New Drug Application for TREANDA for the Treatment of Chronic Lymphocytic Leukemia
5. Cephalon Quarterly Conference Call Invitation
6. Cephalon Announces Strong Third Quarter Financial Results
7. Cephalon Submits Supplemental New Drug Application for FENTORA
8. Cephalon Submits New Drug Application for TREANDA for the Treatment of Patients with Relapsed Indolent Non-Hodgkins Lymphoma
9. Cephalon Presentation Slides for the 26th Annual JPMorgan Healthcare Conference Now Available
10. Cephalons EFFENTORA Receives Positive Opinion from European Regulatory Authorities for the Management of Breakthrough Cancer Pain
11. Cephalon Provides Update on Regulatory Status of the FENTORA Supplemental New Drug Application
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:11/26/2014)... Whitehouse Laboratories is pleased to announce ... (New Jersey) Chamber of Commerce as a member. ... in the North Jersey area, offers Whitehouse Laboratories ... clients in the pharmaceutical and biotechnology areas that ... enables Whitehouse Laboratories a higher level of visibility ...
(Date:11/26/2014)... November 25, 2014 Global biostimulants ... 2019 growing at an estimated CAGR of 12.5%. ... healthy food products with least ecological impacts, farmers ... fertilizers to boost crop yield more effectively & ... that can improve the return on investments. , ...
(Date:11/26/2014)... Theravalues Corporation est fier d,annoncer le lancement de ... Hi Europe 2014 (du 2 au 4 décembre à ... la plus biodisponible actuellement sur le marché, elle ... approuvés par les règlements européens. La ... racine de curcuma ( Curcuma longa ) qui ...
(Date:11/24/2014)... 2014 Five American winners will ... Maktoum Awards for Medical Sciences", in its 8 th ... Emirates , on 15 December 2014. ... The Carter Center which won the Hamdan Award for ... numerous programs that aim to improve health and promote ...
Breaking Biology Technology:Whitehouse Laboratories Joins Morris County Chamber of Commerce 2Whitehouse Laboratories Joins Morris County Chamber of Commerce 32019 Biostimulants Market to Grow at a CAGR of 12.5% Says a New Research Report Available at RnRMarketResearch.com 22019 Biostimulants Market to Grow at a CAGR of 12.5% Says a New Research Report Available at RnRMarketResearch.com 32019 Biostimulants Market to Grow at a CAGR of 12.5% Says a New Research Report Available at RnRMarketResearch.com 4La curcumine présentant la plus haute biodisponibilité bientôt en vente en Europe 2La curcumine présentant la plus haute biodisponibilité bientôt en vente en Europe 3Five US Winners Among Recipients of Hamdan Medical Awards 2
... Milestones, CRANBURY, N.J., Nov. 3 Amicus Therapeutics,(Nasdaq: ... third quarter of,2008. On a reported basis calculated in ... a net loss,attributable to common stockholders of $0.36 per ... three months ended September 30, 2008. As of,September 30, ...
... Nov. 3 Biomoda, Inc. (OTC,Bulletin Board: BMOD) ... announced today that BUYINS.NET, http://www.buyins.net, is initiating ... data to October 2008. From November 2006 to ... BMOD have traded,for a total dollar value of ...
... and GUELPH, Ontario, Nov. 3 LI-COR,Biosciences ... agreement to,distribute LI-COR biotechnology products in Canada ... local presence of Mandel Scientific skilled staff, ... enhance our ability to serve,our Canadian customers," ...
Cached Biology Technology:Amicus Therapeutics Announces Third Quarter 2008 Financial Results 2Amicus Therapeutics Announces Third Quarter 2008 Financial Results 3Amicus Therapeutics Announces Third Quarter 2008 Financial Results 4Amicus Therapeutics Announces Third Quarter 2008 Financial Results 5Amicus Therapeutics Announces Third Quarter 2008 Financial Results 6Amicus Therapeutics Announces Third Quarter 2008 Financial Results 7Amicus Therapeutics Announces Third Quarter 2008 Financial Results 8Amicus Therapeutics Announces Third Quarter 2008 Financial Results 9Amicus Therapeutics Announces Third Quarter 2008 Financial Results 10Amicus Therapeutics Announces Third Quarter 2008 Financial Results 11Biomoda, Inc. (BMOD) SqueezeTrigger Price is $0.27. Approximately 1 Million Shares Shorted Since November 2006 According to Buyins.net Research Report 2Biomoda, Inc. (BMOD) SqueezeTrigger Price is $0.27. Approximately 1 Million Shares Shorted Since November 2006 According to Buyins.net Research Report 3Biomoda, Inc. (BMOD) SqueezeTrigger Price is $0.27. Approximately 1 Million Shares Shorted Since November 2006 According to Buyins.net Research Report 4LI-COR Biosciences and Mandel Scientific Company Inc. Announce Distribution Agreement 2
(Date:11/4/2014)... University School of Medicine announced today that it ... funded by the Bill & Melinda Gates Foundation. ... Gynecology and Reproductive Sciences; and Vice Chair of ... of Medicine will pursue an innovative global health ... to Assess Fetal Neurodevelopment.", Grand Challenges Explorations (GCE) ...
(Date:11/4/2014)... England , November 4, 2014 ... and vertical market growth   Fuel3D , ... has closed a funding round totaling $6.4 million (£4 million). ... million) funding secured earlier this year and paves the way ... in 2015. The funding round was led by ...
(Date:11/3/2014)... -- Research and Markets has announced the addition ... and Companies" to their offering. This ... have already started to play an important role in the ... old fashioned bone marrow transplants. Role of cells in drug ... a part of medical practice. Stem cells are ...
Breaking Biology News(10 mins):Temple University School of Medicine receives Grand Challenges Explorations grant 2Fuel3D Secures $6.4 Million in Expansion Funding 2Fuel3D Secures $6.4 Million in Expansion Funding 3Global Cell Therapy - Technologies, Markets and Companies: 2014 Report 2Global Cell Therapy - Technologies, Markets and Companies: 2014 Report 3
... HOUSTON, May 8, 2012 With the heart having limited ... cause of morbidity and mortality in the developed world. Research ... lecture May 15 at the University of Houston (UH). ... of Texas Southwestern Medical Center, will present "Heart Making and ...
... University scientist and designer from Africa have together created ... with insecticides for warding off mosquitoes infected with malaria, ... the continent. Though insecticide-treated nets are commonly used ... prototype garment can be worn throughout the day to ...
... Association of Pharmaceutical Scientists (AAPS) WHAT: The ... scientists from industry, government, and academia for three ... biotechnology sector of the pharmaceutical sciences. The conference ... Training Course and two AAPS Workshops, transitions into ...
Cached Biology News:New heart repair strategies discussed at UH lecture May 15 2African scientist, designer partner to fashion anti-malaria garment that wards off bugs 2
... This kit is designed for easy transformation ... protocol allows for successful transformation simply by ... reagents with cultured yeast cells. No complicated ... are required. The kit is particularly well ...
... The Bio-Stack Twister II Microplate Handler ... automation solution for integrating BioTeks washers, ... with expandable microplate capacity, ultimate flexibility ... you are adding capacity to single ...
... LabX light balance makes your life easier. It ... acquisition and management for one balance. *Instruments supported: ... TOLEDO AX, MX, UMX, AG, XS, XP, PR, SR, ... balances *Job management: ...
XPLAC (S-17)...
Biology Products: