ViroPharma Announces Meeting of FDA Advisory Committee for Pharmaceutical Science and Clinical Pharmacology on Bioequivalence Recommendations for Oral Vancomycin Hydrochloride Products
EXTON, Pa., May 29 /PRNewswire-FirstCall/ -- The U.S. Food and Drug Administration (FDA) announced today that it will convene a meeting of its Advisory Committee for Pharmaceutical Science and Clinical Pharmacology to discuss bioequivalence
recommendations for oral vancomycin hydrochloride capsule...
MonoSol Rx Successfully Completes Pivotal Bioequivalence Studies for Ondansetron Thin Film NDA
Expects to File NDA with FDA in Early to Mid-2009
WARREN, N.J.,Dec. 2 /PRNewswire/ -- MonoSol Rx, the developers of PharmFilm(R) technology and a drug delivery company specializing in dissolving thin film pharmaceutical products, and Strativa Pharmaceuticals, the proprietary products divi...
Battelle and YuYu Pharma Create the First Joint Bioequivalence Test Experimentation Institution
Opening Ceremony Launches Effort to Transform Korean Pharmaceutical
CHUNCHEON CITY, Korea, Sept. 24 /PRNewswire-USNewswire/ --
Civic and business officials gathered in Chuncheon City Sept. 23 to
open a worldwide bioequivalence
research institute operated by
ViroPharma Announces Support by Advisory Committee of The Office of Generic Drugs Proposed Guidelines for Developing Generic Versions of Oral Vancomycin Hydorchloride
... Office of Generic Drugs (OGD) draft guidelines on bioequivalence
(BE) for Vancocin(R) (vancomycin hydrochloride) ca...issolution methods are sufficient for establishing bioequivalence
for generic vancomycin oral capsules. The Advisor... of the proposed OGD recommendation to demonstrate bioequivalence
through equivalent dissolution in media of pH 1.2,...
ViroPharma Incorporated Reports Second Quarter 2009 Financial Results
... 4, 2009 FDA advisory committee regarding proposed bioequivalence
recommendations for Vancocin.
Conference ...e plan to remain vigorous in our opposition to any bioequivalence
approach considered for use in approving generic f...tical Science and Clinical Pharmacology to discuss bioequivalence
recommendations for oral vancomycin hydrochloride ...
ADVENTRX Pharmaceuticals Announces Closing of Financing
...uptcy Code; the risk that ADVENTRX will reassess the results of the ANX-530 bioequivalence
study and determine to conduct additional bioequivalence
studies of ANX-530, including in humans; the potential for regulatory autho...
Putney, Inc. Enters the $175M Annual Veterinary NSAID Market
...responding veterinarians nationwide indicated they prescribe and dispense branded carprofen medications. Putney's carprofen caplets have demonstrated bioequivalence
to Pfizer's Rimadyl(R) caplets in an FDA approved study and will be available in the same strengths (25mg, 75mg and 100mg caplets) and convenient pack...
MonoSol Rx Announces FDA Acceptance of NDA for Ondansetron Orally Dissolving Film Strip
...th highly- and moderately-emetogenic chemotherapy, radiotherapy and surgery. The NDA is supported by positive data from successfully completed pivotal bioequivalence
studies against ondansetron ODT (orally disintegrating tablets), both with and without water. Pursuant to Prescription Drug User Fee Act (PDUFA) guide...
In the Case of Epilepsy, Generic Drugs and Random Product Substitution are Not Always "Good Medicine"
... being planned by the National Institute for Neurological Disorders and Stroke (NINDS), which will examine the issue of therapeutic equivalence versus bioequivalence
as well as the potential dangers when switching from a brand name to a generic or being subject to the random substitution of one generic for another....
FDA Approves Lamictal(R) ODT(TM) Orally Disintegrating Tablets
...like Lamictal ODT , offer an option for patients who have difficulty swallowing tablets."
Lamictal ODT was approved based on the demonstrated bioequivalence
of Lamictal ODT to Lamictal Tablets and was developed in collaboration with Eurand N.V. (Nasdaq: EURX ). Lamictal ODT is the only antiepilepti...
Bioequivalence in Medical Technology
ADVENTRX Announces Results From ANX-514 Bioequivalence Study
- Updates guidance regarding strategic transaction process
SAN DIEGO, May 7 /PRNewswire-FirstCall/ -- ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX ) today announced results from its bioequivalence
study of ANX-514 (docetaxel emulsion). ANX-514 was determined to have comparable overall sa...
ViroPharma Submits Comments on Vancocin(R) Draft Bioequivalence Guidance
- Company Calls for Additional Scientific Data and Withdrawal of Guidance -
EXTON, Pa., March 18 /PRNewswire-FirstCall/ -- ViroPharma Incorporated (Nasdaq: VPHM ) today announced its submission to the U.S. Food and Drug Administration (FDA) of comments on FDA's Office of Generic Drugs' (OGD...
ADVENTRX Completes Patient Enrollment in ANX-514 Bioequivalence Study
SAN DIEGO, Feb. 5 /PRNewswire-FirstCall/ -- ADVENTRX Pharmaceuticals, Inc. (NYSE Alternext US: ANX), announced today that it has completed patient enrollment in its bioequivalence
study of ANX-514 (docetaxel emulsion for injection). The Company is on track to announce results from this study in th...
MannKind Reports Successful Completion of Device Bioequivalence Trial
VALENCIA, Calif., Jan. 13 /PRNewswire-FirstCall/ -- MannKind Corporation (Nasdaq: MNKD ) today announced successful completion of its trial to demonstrate equivalence of its commercial inhaler to the version of the device that was used in clinical trials to deliver AFRESA(TM), MannKind's ultra...
Insmed Announces First Human Bioequivalence Data for a Follow-on Biologic by a U.S. Company
Company Intends to Request Meeting with FDA Regarding Possible Phase III Trial Based on Human Data Demonstrating Bioequivalence
of INS-19 to Neupogen(R)
RICHMOND, Va., July 10, 2008 /PRNewswire-FirstCall/ -- Insmed Inc.
(Nasdaq: INSM ), a developer of follow-on b...
ADVENTRX Announces ANX-530 Safety Data From Registrational Bioequivalence Clinical Study
- ANX-530 Demonstrates Statistically Significant Reductions in Selected Safety Observations
- Abstract to be published in 2008 Proceedings of the American Society of Clinical Oncology
SAN DIEGO, May 16 /PRNewswire-FirstCall/ -- ADVENTRX Pharm...
MonoSol Rx Completes Thin Film Ondansetron Pilot Bioequivalence Study
WARREN, N.J., Feb. 21 /PRNewswire/ -- MonoSol Rx, a drug delivery
company specializing in dissolving thin film pharmaceutical products, today
announced that it has successfully completed a pilot clinical study for its
thin film formulation of ondansetron, a selective 5-HT3 receptor antagonist
Catalyst Pharmaceutical Partners, Inc. Announces Top-Line Results
of Its Bioequivalence Study of CPP-109 (Vigabatrin), the Company's
Investigational Drug to Treat Cocaine and Methamphetamine Addiction
CORAL GABLES, Fla., May 09, 2007 /PRNewswire-FirstCall/ --
Catalyst Pharmaceutical Partners, Inc. announced today positive
initial, top-line results from a bioequivalence
that CPP-109 (Catalyst's Vigabatrin Tablets) is bioavailable and
bioequivalent to Sabril Tablets, the versi...
Current Status of the Development Programs of New Indications and Formulations for Aricept(R) for Enhancing Patient Value
3. Transdermal Patch Formulation
Clinical trials of a once-a-week transdermal patch formulation of donepezil, which include a bioequivalence
study compared to the currently marketed formulation of donepezil, are currently being conducted by Teikoku Pharma USA, Inc. in the United States. An ...
Strativa Pharmaceuticals Provides Product Pipeline Update
...nausea and vomiting, and prevention of post-operative nausea and vomiting.
A program consisting of three separate pivotal studies comparing the bioequivalence
of ondansetron ODFS 8mg to Zofran ODT(R) 8mg was completed in December 2008 and supports the NDA filing of ondansetron ODFS. The pharmacokinetic resu...
Bioequivalence in Medical Dictionary
..... New Drug Application (ANDA): Generics . Orange Book Query ... the Director, Office of Generic Drugs ... Office of Generic Drugs: Chemistry and bioequivalence
... Dictionary.com - Largest free online dictionary and audio pronunciation. ... Popular Daily Crossword Crossword Solver Full Text Translator Too...
Bioequivalence in Biological News
Bioequivalence in Biological Technology
Charleston Laboratories, Inc. Completes Exploratory Bioequivalence Study of CL-108
CHARLESTON, S.C., May 18 /PRNewswire/ -- Charleston Laboratories, Inc., an emerging specialty pharmaceutical company dedicated to reducing opioid-induced nausea and vomiting (OINV) in opioid pharmaceuticals, announced today they successfully completed the Exploratory Bioequivalence
Study on CL-108...
ChemImage and Next Breath Structure Partnership to Validate Bioequivalence Testing for Nasal Spray Suspensions
Testing Will Help Advance Technology to Find a Faster, More Accurate and Repeatable Method for Drug-Particle Sizing
PITTSBURGH, April 1 /PRNewswire/ -- ChemImage, ( www.chemimage.com ) today announces a strategic research partnership with Next Breath, LLC ( www.nextbreath.net ), a leading Con...
Strativa Pharmaceuticals Announces Successful Completion of Bioequivalence Studies for Ondansetron Thin Film
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...
ViroPharma Provides Update on Upcoming FDA Advisory Committee Meeting to Discuss Bioequivalence of Locally Acting Gastrointestinal Drugs
EXTON, Pa., July 8 /PRNewswire-FirstCall/ -- ViroPharma Incorporated
(Nasdaq: VPHM ) has been informed by U.S. Food and Drug Administration (FDA)
that the July 23, 2008 meeting of its Advisory Committee for Pharmaceutical
Science and Clinical Pharmacology is not intended to discuss specifical...
Pharsight to Present on IVIVC at Bioequivalence & Bioavailability Strategies Conference
Talk Will Cover the Use of Pharsight Software for In-Vitro / In-Vivo Correlation Modeling in Drug Development
MOUNTAIN VIEW, Calif., June 23 /PRNewswire-FirstCall/ -- Pharsight(R)
Corporation (Nasdaq: PHST ), a leading provider of software, strategic
consulting, and regulator...
ANX-530 Demonstrates Equivalent Pharmacokinetics to Navelbine(R) in a Registrational Bioequivalence Clinical Study
ADVENTRX Presents Data at the 2008 American Association for Cancer Research Annual Meeting
SAN DIEGO, April 15 /PRNewswire-FirstCall/ -- ADVENTRX Pharmaceuticals,
Inc. (Amex: ANX ) announced that it presented pharmacokinetic data from its
ADVENTRX Pharmaceuticals Announces Plans for Remainder of 2009
...e to evaluate the data from its recently-completed bioequivalence
study of ANX-514 and plans to seek a meeting with ... ADVENTRX will reassess the results of the ANX-530 bioequivalence
study and determine to conduct additional bioequivalence
studies of ANX-530, including in humans; the poten...
Strativa's New Drug Application for Ondansetron Orally Dissolving Film Strip Accepted by FDA
...lve on the tongue, was developed using MonoSol Rx' proprietary PharmaFilm(TM) thin film technology. In clinical studies, this formulation demonstrated bioequivalence
to ondansetron orally disintegrating tablets (ODT), both with and without water. Pursuant to Prescription Drug User Fee Act (PDUFA) guidelines, Strati...
Data for SemBioSys' insulin to be presented at the American Diabetes Association's 69th Scientific Sessions
...n will take place at the Morial Convention Center Poster Hall E on Sunday, June 7th and is entitled: "Analytical Characterization, Safety and Clinical bioequivalence
of Recombinant Human Insulin from Transgenic Plants," by Joseph Boothe and colleagues. The abstract for the presentation is available via the ADA webs...
ViroPharma Incorporated Reports First Quarter 2009 Financial Results
...uidance is based upon our plans to remain vigorous in our opposition to any bioequivalence
approach considered for use in approving generic formulations of Vancocin t...n related submissions or that our efforts to oppose the FDA's December 2008 bioequivalence
guidance for Vancocin will be successful. We cannot predict the timeframe i...