Navigation Links
Strativa Pharmaceuticals Announces Successful Completion of Bioequivalence Studies for Ondansetron Thin Film
Date:12/2/2008

On Track to File NDA with FDA in Early to Mid-2009

WOODCLIFF LAKE, N.J., Dec. 2 /PRNewswire-FirstCall/ -- Strativa Pharmaceuticals, the proprietary products division of Par Pharmaceutical Companies, Inc. (NYSE: PRX) today announced that its development partner, MonoSol Rx, reported the successful completion of all pivotal bioequivalence studies for a thin film formulation of ondansetron. The ondansetron thin film product is being developed for the prevention of chemotherapy-induced nausea and vomiting, prevention of nausea and vomiting associated with radiotherapy, and post-operative nausea and vomiting.

Subject to final review of the data and discussions with the Food and Drug Administration (FDA), it is anticipated that Strativa and MonoSol Rx could file a New Drug Application (NDA) in early to mid 2009.

In June 2008, MonoSol Rx and Strativa entered into an exclusive licensing agreement under which Strativa acquired the U.S. commercialization rights to the thin film formulation of ondansetron from MonoSol Rx. Under terms of the agreement, MonoSol Rx will receive milestone payments prior to commercial launch and sales-based milestones that could total $23.5 million as well as payments for the purchase of product supply and royalties on net sales. The successful achievement of all pivotal bioequivalence studies triggered a milestone payment to MonoSol Rx.

John A. MacPhee, president of Strativa, said, "Completion of the pivotal bioequivalence trials is a significant milestone in the development and commercialization process for our thin film ondansetron formulation. Working with MonoSol Rx we were able to demonstrate that the thin film formulation is bioequivalent to the FDA approved Zofran ODT(R) product in all human clinical trials."

Anti-emetic therapies constit
'/>"/>

SOURCE Par Pharmaceutical Companies, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related biology technology :

1. Strativa Pharmaceuticals, a Division of Par Pharmaceutical, Announces the Discontinuation of the Development Program for Pafuramidine
2. Strativa Pharmaceuticals, the Proprietary Products Division of Par Pharmaceutical, Provides an Update on Development Status of Pafuramidine and Other in-Licensed Products
3. Introducing Strativa Pharmaceuticals
4. Cerimon Pharmaceuticals Appoints James S. Shannon, M.D., to Board of Directors
5. Webcast Alert: Regulus Therapeutics, Alnylam Pharmaceuticals and Isis Pharmaceuticals Announce New Nature Publication on miR-21 Conference Call
6. Cell Therapeutics, Inc. (CTI) to Discuss Zevalin Joint Venture with Spectrum Pharmaceuticals
7. Spectrum Pharmaceuticals and Cell Therapeutics to Jointly Market ZEVALIN, a Proprietary, Marketed Oncology Drug
8. Cephalon and Eurand File Patent Infringement Lawsuit Against Mylan Pharmaceuticals and Barr Pharmaceuticals
9. Anadys Pharmaceuticals to Present at the Piper Jaffray Health Care Conference
10. Celator(R) Pharmaceuticals to Present at Piper Jaffray Health Care Conference and Mid-Atlantic Capital Conference
11. Indevus Pharmaceuticals Announces Fiscal 2008 Year End and Fourth Quarter Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/10/2014)... July 10, 2014 Product and ... very low abundance and are often “lost in ... time-consuming. , Join presenters Dr. Rowel Tobias, Senior ... John Anders, Head of Quality at Nanotherapeutics, Inc., ... that can speed detection and quantitation while achieving ...
(Date:7/10/2014)... Robert Harman, DVM, Founder and CEO of Vet-Stem, ... announce the relaunch of his highly informative blog, now named ... “ What are Stem Cells ?” Dr. Harman’s purpose ... in the basics of stem cell therapy so that pet ... of treatment when considering regenerative medicine. , A veterinarian by ...
(Date:7/10/2014)... 10, 2014 On July 9 ... , presented Russia,s first national ... The Company is developing a unique project called ... develops a number of innovative drugs based on monoclonal ... ceremony took place at the International Exhibition "Innoprom 2014" ...
(Date:7/10/2014)... D.C., April 15, 2014 -- According to the ... to nuclear security comes from terrorists acquiring sufficient ... to construct a crude nuclear explosive device. The ... nuclear trafficking have involved gram-level quantities, which can ... , According to a new study appearing this ...
Breaking Biology Technology:Novel Ms Techniques Speed Detection of Biopharmaceutical Product and Process Impurities, New Webinar Hosted by Xtalks 2Robert Harman, DVM Talks About What Stem Cells are in His Latest Blog Series for Vet-Stem, Inc. 2Robert Harman, DVM Talks About What Stem Cells are in His Latest Blog Series for Vet-Stem, Inc. 3Dmitry Medvedev Presented BIOCAD the First National "Industry" Award 2Sensitive detection method may help impede illicit nuclear trafficking 2
... 7, 2011 Regado Biosciences, Inc., a privately ... with active control agents, announced the presentation of ... Company,s Phase 2b RADAR trial of REG1, Regado,s ... at the Transcatheter Cardiovascular Therapeutics (TCT) Symposium meeting ...
... Inc. (NYSE AMEX: IBIO ) today announced that ... its 2011 Annual Stockholders Meeting to be held December 8, 2011 ... at 11:00 AM ET. Although only stockholders of ... will be entitled to vote at the meeting, anyone with proof ...
... The shortlist of contenders for the highest ... narrowed tonight as the winners of the Siemens ... Finals were announced.  Cancer stem cell research earned ... Angela Zhang of Cupertino, California.  Research on molecular ...
Cached Biology Technology:Regado Biosciences, Inc. Presents Positive Efficacy and Safety Substudy Data from the Phase 2b RADAR Trial for the REG1 Anticoagulation System at the Transcatheter Cardiovascular Therapeutics (TCT) Symposium 2011 2Regado Biosciences, Inc. Presents Positive Efficacy and Safety Substudy Data from the Phase 2b RADAR Trial for the REG1 Anticoagulation System at the Transcatheter Cardiovascular Therapeutics (TCT) Symposium 2011 3Regado Biosciences, Inc. Presents Positive Efficacy and Safety Substudy Data from the Phase 2b RADAR Trial for the REG1 Anticoagulation System at the Transcatheter Cardiovascular Therapeutics (TCT) Symposium 2011 4iBio Sets Record Date and Location for December 8 Annual Meeting of Stockholders 2Biochemistry and Bioengineering Research Brings California Students Closer to Nation's Highest Science Honor for High School Students 2Biochemistry and Bioengineering Research Brings California Students Closer to Nation's Highest Science Honor for High School Students 3Biochemistry and Bioengineering Research Brings California Students Closer to Nation's Highest Science Honor for High School Students 4Biochemistry and Bioengineering Research Brings California Students Closer to Nation's Highest Science Honor for High School Students 5
(Date:7/11/2014)... The increased risk of kidney injury related to ... reflects the mass of HES molecules, according to a ... of the International Anesthesia Research Society (IARS). , The ... of HES on cultured human renal proximal tubule cells ... and colleagues of University Hospital Wrzburg, Austria. Other ...
(Date:7/11/2014)... 1 can inhibit voltage-gated calcium channel, decrease ... However, some scholars demonstrated that cannabinoid receptor ... and increase neurotransmitter release. Dr. Yi Zhang ... Tongji Medical College, Huazhong University of Science ... and calcium imaging in cultured trigeminal ganglion ...
(Date:7/10/2014)... In Santa Fe, Albuquerque, and other major cities in ... watered with treated municipal wastewater rather than precious potable ... more than 40% of all golf courses receive treated ... courses. , Additionally, golf courses and homeowners alike ... nutrient in fertilizer is nitrate. A New Mexico State ...
Breaking Biology News(10 mins):In lab studies, hydroxyethyl starch has direct harmful effects on kidney cells 2'Tailored' water -- the latest in lawn care 2
... -- Findings from a first-of-its-kind study by Indiana University ... or fantasies -- can lead to female orgasm. ... phenomenon, sometimes called "coregasm" because of its association with ... media for years, said Debby Herbenick, co-director of the ...
... Georgetown University Medical Center have revealed how a mutation in ... to effectively pass along appetite suppressing signals from the body ... obesity caused by a voracious appetite. , Their study, published ... might be a way to stimulate expression of that gene ...
... a proton the bare nucleus of a hydrogen atom ... a molecule, the result is a hydrogen bond, in which ... electrons. Conventional wisdom has it that proton transfers can only ... networks that can connect and reconnect to alter molecular properties. ...
Cached Biology News:Study: Exercise can lead to female orgasm, sexual pleasure 2Study: Exercise can lead to female orgasm, sexual pleasure 3Researchers reveal how a single gene mutation leads to uncontrolled obesity 2A surprising new kind of proton transfer 2A surprising new kind of proton transfer 3A surprising new kind of proton transfer 4
Mouse monoclonal antibody raised against a full length recombinant YARS. NCBI Entrez Gene ID = YARS...
... Sight DS-L2 imaging controller is a successor ... and allows users to comfortably observe, record ... controller features an 8.4 inch LCD (XGA) ... of Nikon cameras including the DS-Fi1 , ...
... is a premium quality recombinant form of ... is suitable for a wide range of ... and reproducible performance, each preparation is extensively ... assays. NovaTaq DNA Polymerase possesses an integral ...
Mouse polyclonal antibody raised against a partial recombinant TSEN2. NCBI Entrez Gene ID = 80746...
Biology Products: