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Bioequivalence in Medical News

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 Industry 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 International Scientifi...

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 study demonstrating 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

...tment options. 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

Generic

..... 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

InVitria Announces Launch of Recombinant Albumin for Diagnostics

...ommercial alternative. In addition, stability over time was significantly improved with Recombinant Albumin-DX (Lipid-Free). Tests have also shown the bioequivalence of the Recombinant Albumin-DX to native human serum albumin (HSA).     “InVitria is committed to developing high performance, regu...

Market testing of dietary supplements and drugs underscores value of USP's public health programs

...d that these monographs allow different dissolution requirements. This is appropriate on the assumption that the FDA has reviewed and found acceptable bioequivalence studies for formulations conforming to the monographs. USP does not verify drug products approved by the FDA. ...
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 registrational bioequivalenc...

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...
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