Navigation Links
Cephalon and Eurand Announce Notification of Generic Filing for Cyclobenzaprine Hydrochloride Extended-Release Capsules
Date:10/21/2008

FRAZER, Pa. and PHILADELPHIA, Oct. 21 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq: CEPH) and Eurand NV (Nasdaq: EURX) today announced receipt of a Paragraph IV Certification Notice Letter on October 20, 2008 regarding an Abbreviated New Drug Application (ANDA) submitted to the U.S. Food and Drug Administration (FDA) by Mylan Pharmaceuticals, Inc., requesting approval to market and sell a generic version of the 15 mg and 30 mg strengths of AMRIX(R) (Cyclobenzaprine Hydrochloride Extended-Release Capsules). In the Notice Letter, Mylan alleges that the U.S. Patent Number 7,387,793, entitled "Modified Release Dosage Forms of Skeletal Muscle Relaxants," issued to Eurand is invalid, unenforceable and/or will not be infringed by Mylan's manufacture, use or sale of the product described in Mylan's ANDA submission. The Eurand patent covers extended-release formulations containing the muscle relaxant cyclobenzaprine and expires on February 26, 2025. Cephalon has a three-year period of marketing exclusivity for AMRIX that extends until February 2010.

Eurand, the developer of AMRIX, and Cephalon, the exclusive licensee and marketer of AMRIX in the United States, currently are reviewing the Notice Letter. By statute, if Eurand initiates a patent infringement lawsuit against Mylan within 45 days of the Notice Date, then the FDA would be automatically precluded from approving the Mylan ANDA until the earlier of a district court decision finding the patent invalid or not infringed or 30 months from the receipt of the Noti
'/>"/>

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

Page: 1 2 3 4

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:4/21/2015)... April 21, 2015 Ampio Pharmaceuticals, Inc. (NYSE ... investor call on Thursday, April 23, 4:30 p.m. ET. ... as follows: Investor call information: ... 789-4877 International toll number: (925) 418-7845 Participant Passcode: 32888538 ... Tina Amirkiai , tina.amirkiai@fleishman.com . ...
(Date:4/21/2015)... , April 21, 2015  Cryoport, ... of advanced cryogenic logistics solutions for the ... stem cells, cell lines, clinical research organizations, ... that Dr. Mark W. Sawicki , ... 3rd Annual BioLogistics Summit in San ...
(Date:4/21/2015)... April 21, 2015  scPharmaceuticals, Inc., a ... products for subcutaneous delivery, announced today that ... its investigational proprietary drug product, Furosemide Injection ... with congestive heart failure. Concurrently ... a proprietary patch pump.  The patch pump ...
(Date:4/21/2015)... Bruno, CA (PRWEB) April 21, 2015 ... CRO, will sponsor and exhibit at the ACRP 2015 ... Salt Lake City, Utah. The Association of Clinical Research ... annual clinical research conference solely focused on the conduct ... membership, training and development, and widely recognized industry certifications. ...
Breaking Biology Technology:Ampio Announces Investor Call on Thursday, April 23, 4:30 p.m. ET 2Cryoport to Present at the 3rd Annual BioLogistics Summit in San Francisco, CA 2Cryoport to Present at the 3rd Annual BioLogistics Summit in San Francisco, CA 3scPharmaceuticals Announces Start of Pivotal Trial for Novel Furosemide Solution for Subcutaneous Delivery 2scPharmaceuticals Announces Start of Pivotal Trial for Novel Furosemide Solution for Subcutaneous Delivery 3PRC Clinical Sponsors The ACRP 2015 Global Conference And Meets Biotech Companies in the Salt Lake City Area. 2
... Feb. 28 InterMune, Inc.,(Nasdaq: ITMN ) ... Officer of InterMune, will present at Susquehanna,s Second ... on March 5, 2008,at 2:30 p.m. EST., ... presentation, investors and other,interested parties may log on ...
... ... Feb. 28 Cepheid (Nasdaq:,CPHD) today announced financial results for the fourth quarter and full,year ... Total revenues of $129.5 million, a 48 percent increase from $87.4 ... - Total product sales of $116.5 million, a 41 percent increase from ...
... N.C., Feb. 28 PPD, Inc. (Nasdaq:,PPDI) today ... (NDA) for alogliptin, a highly selective DPP-4 inhibitor ... accepted for filing by the U.S.,Food and Drug ... Under PPD,s agreement with Takeda, the FDA,s ...
Cached Biology Technology:InterMune to Present at the SIGnificant Options in Healthcare Conference 2Cepheid Reports Fourth Quarter and Full Year 2007 Results 2Cepheid Reports Fourth Quarter and Full Year 2007 Results 3Cepheid Reports Fourth Quarter and Full Year 2007 Results 4Cepheid Reports Fourth Quarter and Full Year 2007 Results 5Cepheid Reports Fourth Quarter and Full Year 2007 Results 6Cepheid Reports Fourth Quarter and Full Year 2007 Results 7Cepheid Reports Fourth Quarter and Full Year 2007 Results 8Cepheid Reports Fourth Quarter and Full Year 2007 Results 9Cepheid Reports Fourth Quarter and Full Year 2007 Results 10Cepheid Reports Fourth Quarter and Full Year 2007 Results 11Cepheid Reports Fourth Quarter and Full Year 2007 Results 12Cepheid Reports Fourth Quarter and Full Year 2007 Results 13Cepheid Reports Fourth Quarter and Full Year 2007 Results 14PPD Confirms Takeda's NDA Filing of Alogliptin with U.S. Food and Drug Administration 2
(Date:4/14/2015)... YORK , April 14, 2015  HYPR ... IDentity Online (FIDO ® ) Alliance tm , ... specifications. FIDO members commit to share technology and ... methods that are interoperable, more secure and private, ... enable biometric identity verification that protects sensitive user ...
(Date:4/13/2015)... April 13, 2015  higi, a leading cloud-based consumer ... more fully engage with their communities around health and ... protected and secure API.  ... most accessible, affordable, and convenient vehicle to receive validated ... The API will allow higi,s trusted ...
(Date:4/8/2015)... , April 8, 2015  Infinisource, a ... and services, and Morpho, a leading supplier of ... to produce the market,s most advanced biometrically-enabled time ... iSolved NXG time clock is setting a bold, ... labor data for the small and mid-size employer. ...
Breaking Biology News(10 mins):HYPR Corp. Joins the FIDO Alliance 2HYPR Corp. Joins the FIDO Alliance 3higi Launches Seamless Access to HIPAA-Compliant Health Outcomes and Activity Data 2higi Launches Seamless Access to HIPAA-Compliant Health Outcomes and Activity Data 3iSolved Time Clock Offers Unmatched Accuracy due to Morpho Biometrics 2iSolved Time Clock Offers Unmatched Accuracy due to Morpho Biometrics 3
... York December 22, 2009): Interferon gamma is a protein ... in white blood cells that cause tuberculosis. In a ... NYU Langone Medical Center have discovered that in addition to ... cells, also respond to interferon gamma and also protect mice ...
... ground too fast and you will crash and burn; too slow ... monitoring the speed of images moving across their eyes. By slowing ... the retina remains constant, bees manage to control their approach. But ... how do bees adapt to landing on surfaces ranging from the ...
... Scott & White Healthcare in Temple, Texas, found that a new ... is unique in that it works both by stopping the cancer ... the immune system to destroy breast cancer cells and keeps them ... work in both ways, while all other treatments work in one ...
Cached Biology News:Final moments of bee landing tactics revealed 2Final moments of bee landing tactics revealed 3Scott & White Healthcare researcher finds success with new anti-cancer drug 2
Anti-TNKS2 Polyclonal AntibodyOther Sub-Family: not assigned-Other Applications: ELISA, Western Blot...
Rabbit Anti-Human Janus Kinase 2 (JAK2 Polyclonal Antibody Family: Protein Kinase Sub-Family: TYK2/JAK Applications: ELISA, Western Blot...
Goat polyclonal to Lipocalin 2...
Human GCP-2 is a member of the CXC family of chemokines. It also promotes neutrophil chemotaxis and deganulation. GF063 is an 8.0 kDa protein containing 73 amino acid residues....
Biology Products: