Bioequivalent

ViroPharma Announces Support by Advisory Committee of The Office of Generic Drugs Proposed Guidelines for Developing Generic Versions of Oral Vancomycin Hydorchloride

...cer. "While we're disappointed with the vote, we hope that the OGD will take every precaution to ensure that CDI patients will be treated with truly bioequivalent versions of vancomycin, given the life-threatening nature of the disease." The Advisory Committee was asked if the proposed OGD guidelines an...

Putney, Inc. Enters the $175M Annual Veterinary NSAID Market

...he development of generic drugs for pets, has launched carprofen caplets, a bioequivalent generic version of the canine medication Rimadyl(R) caplets. Putney's carpr...DA for pets. "With carprofen caplets, Putney is delivering a high quality, bioequivalent generic option to veterinarians to help pet owners afford to treat pets," s...

More stringent evaluation on the use of generic medications in thoracic transplantation

...healthy and face the challenges of chronic disease, effects of drug therapy on non-translated organs, and interacting medications. "A presumably bioequivalent generic product when applied in the setting of transplantation often demonstrates a different and unanticipated pharmacokinetic profile. This issue i...

In the Case of Epilepsy, Generic Drugs and Random Product Substitution are Not Always "Good Medicine"

...their brand name counterparts (i.e., the same clinical efficacy and safety profile). In fact, for approval, the FDA only requires that the generic be bioequivalent (i.e., within a certain range of a brand name drug's potency as measured by single-dose blood tests in healthy volunteers). Additionally, pharmacies,...

NovaBay Pharmaceuticals, Inc. Reports First Quarter 2009 Financial Results

...ny focused on developing its proprietary and patented Aganocide compounds, first-in-class, novel, synthetic anti-infective product candidates that are bioequivalent to the active antimicrobial molecules generated within white blood cells to treat and prevent a wide range of infections without causing resistance. ...

DRAXIMAGE(R)'s generic Sestamibi Approved for launch in USA

...ministration (FDA) approval for the Company's Abbreviated New Drug Application (ANDA) for DRAXIMAGE(R)'s generic Sestamibi. The product is found to be bioequivalent and therapeutically equivalent to reference listed drug Cardiolite(R). DRAXIMAGE(R) Sestamibi, is a generic kit used in the preparation of Technetiu...

Strativa Pharmaceuticals Provides Product Pipeline Update

...ng of ondansetron ODFS. The pharmacokinetic results of each study demonstrate that a single dose of ondansetron ODFS, taken with or without water, is bioequivalent to Zofran ODT, taken under similar conditions. The antiemetic market totaled 4.1 million prescriptions in 2008. Ondansetron was the prescript...

Caraco Pharmaceutical Laboratories, Ltd. Markets Generic Topamax(R) Tablets

...of age and older with seizures associated with Lennox-Gastaut syndrome. These generic versions of Topamax 25 mg, 50 mg, 100 mg, and 200 mg tablets are bioequivalent to Topamax(R) which is a registered trademark of Ortho McNeil Janssen Pharmaceuticals, Inc. According to IMS Data, these strengths of Topiramate had U...

District Court Decision Received in CONCERTA(R) Patent Case

...additional bioequivalence metrics to ensure that the approval of any generic versions of CONCERTA(R) extended-release methylphenidate tablets are both bioequivalent and clinically equivalent to the innovator product. IMPORTANT SAFETY INFORMATION Talk to your healthcare professional for a proper diagnosis...

NovaBay Pharmaceuticals' Scientific Advisor Receives American Chemical Society's Highest Award

...maceuticals is a mid-stage biopharmaceutical company developing first-in-class, novel, synthetic anti-infective product candidates. These products are bioequivalent to the active antimicrobial molecules generated within white blood cells to treat and prevent a wide range of infections without developing resistance...

Bioequivalent in Medical Technology

Study: Identical Doses of BiDil Components Are Not Bioequivalent to the Fixed Dose Combination-BiDil-Used in A-HeFT

NEW ORLEANS, La.--(BUSINESS WIRE)--Mar 26, 2007 - A study comparing the formulations of isosorbide dinitrate (ISDN) and hydralazine (HYD) used in V-HeFT I and V-HeFT II, and BiDil, the proprietary fixed dose combination, used in the African American Heart Failure Trial (A-HeFT) demonstrated no bioe...

Procter & Gamble Pharmaceuticals Launches Asacol(R) HD (mesalamine) Delayed-Release Tablets

... compared to 59 percent of patients (n=77/130) who took Asacol 400 mg tablets at 2.4 g/day.(1,2) One Asacol HD 800 mg tablet has not been shown to be bioequivalent to two Asacol 400 mg tablets. In addition, Asacol HD at 4.8 g/day demonstrated rapid improvement in rectal bleeding and stool frequency. At thr...

Alcon Commences Phase 2 Clinical Trial of NovaBay's NVC-422 for Viral Conjunctivitis

...mpany focused on developing its proprietary and patented Aganocide(R) compounds, which are novel, synthetic anti-infective product candidates that are bioequivalent to the active antimicrobial molecules generated within white blood cells to treat and prevent a wide range of infections without causing bacterial res...

NovaBay(R) Pharmaceuticals Enters into Agreement to Broaden Intellectual Property Estate and Expand Clinical Opportunities for Its Aganocide(R) Compounds

...ny focused on developing its proprietary and patented Aganocide compounds, first-in-class, novel, synthetic anti-infective product candidates that are bioequivalent to the active antimicrobial molecules generated within white blood cells to treat and prevent a wide range of infections without causing resistance. ...

Strativa Pharmaceuticals Provides Product Pipeline Update

...ng of ondansetron ODFS. The pharmacokinetic results of each study demonstrate that a single dose of ondansetron ODFS, taken with or without water, is bioequivalent to Zofran ODT, taken under similar conditions. The antiemetic market totaled 4.1 million prescriptions in 2008. Ondansetron was the prescript...

NovaBay Pharmaceuticals Announces Lead Anti-infective Product Candidate, NVC-422, Shown to be Effective in Treating Topical Fungal Infection

...e (skin fungus) infections. The study of NVC-422, which is a synthetic bioequivalent form of the most effective and rapidly-acting anti-infective molecules prod...first-in-class, novel, synthetic anti-infective product candidates that are bioequivalent to the active antimicrobial molecules generated within white blood cells to...

New Keppra XR(TM) Data Highlight Its Role for Patients with Partial-Onset Seizures

...demonstrated that an investigational 750 mg tablet strength of Keppra XR is bioequivalent to the approved 500 mg tablet when these are each combined to achieve a 1,5...g dose. Results show that a single dose of 2 x 750 mg Keppra XR tablets was bioequivalent to a 3 x 500 mg single dose of Keppra XR in healthy adults, and that food i...

Takeda's Investigational PPI TAK-390MR Demonstrated Higher Healing Rates Compared to Lansoprazole as the Severity of Erosive Esophagitis Grade Increased, a New Integrated Analysis Showed

... Erosive Esophagitis. Abstract P24, Poster Presentation, Sunday October 5 -- TAK-390MR, a Novel Dual Delayed Release Formulation of a PPI, is bioequivalent When Administered as Granules Sprinkled Over Applesauce or as an Intact Capsule. Abstract P394, Poster, Monday, October 6 About TAK-390MR ...

Catalyst Pharmaceutical Partners Reports Fourth Quarter and Year-End 2007 Financial Results

..., Catalyst submitted to the U.S. Food & Drug Administration (FDA) the results of a bioequivalence study demonstrating that CPP-109 is bioavailable and bioequivalent to Sabril(R) Tablets, the version of vigabatrin marketed in Europe by Sanofi Aventis. In December 2007, Catalyst announced positive initial top-line...

Antares Pharma Announces Positive Results from Application Site Study for Anturol

..., thighs or shoulders alternatively with 10 days washout between doses. The results of the study were that each of the three sites evaluated delivered bioequivalent amounts of ANTUROL(R). Additionally, the ratio of plasma levels of R- to S- enantiomers of the active metabolite was lower following gel application (...

Bioequivalent in Biological Technology

NovaBay(R) Pharmaceuticals Names Roy J. Wu as Senior Vice President for Business Development

...mpany focused on developing its proprietary and patented Aganocide(R) compounds, which are novel, synthetic anti-infective product candidates that are bioequivalent to the active antimicrobial molecules generated within white blood cells to treat and prevent a wide range of infections without causing bacterial res...

NovaBay(R) Pharmaceuticals to Present at Jesup & Lamont 2009 Growth Stock Conference

...company focused on developing its proprietary and patented Aganocide compounds, which are novel, synthetic, anti-infective product candidates that are bioequivalent to the active antimicrobial molecules generated within white blood cells to treat and prevent a wide range of infections without causing bacterial res...

Caraco Pharmaceutical Laboratories, Ltd. Markets Generic Casodex(R) Tablets

...easing hormone (LHRH) analog for the treatment of Stage D2 metastatic carcinoma of the prostate. This generic version of Bicalutamide 50 mg tablets is bioequivalent to Casodex(R) which is a registered trademark of AstraZeneca group of companies. According to IMS Data, Casodex had US sales of approximately $314 mil...

Data for SemBioSys' insulin to be presented at the American Diabetes Association's 69th Scientific Sessions

...manufactured using the Company's proprietary platform, which allows for highly scalable, low cost production. The trial demonstrated that SBS-1000 was bioequivalent to Eli Lilly's Humulin(R) R, a widely-used human insulin in North America, with the expected safety profile. Additionally, SBS-1000 in humans showed p...

SemBioSys provides update on insulin program

...h 2009, SemBioSys reported results from the Phase I/II trial of its recombinant human insulin (SBS-1000) in human volunteers. SBS-1000 was shown to be bioequivalent to Eli Lilly's Humulin(R) R, a widely-used human insulin in North America. "Based on prior discussions with third parties, we believe that our recen...

NovaBay Pharmaceuticals, Inc. Announces Fourth Quarter and Full Year 2008 Financial Results

...ny focused on developing its proprietary and patented Aganocide compounds, first-in-class, novel, synthetic anti-infective product candidates that are bioequivalent to the active antimicrobial molecules generated within white blood cells to treat and prevent a wide range of infections without causing resistance. ...

NovaBay and Galderma Enter Into Global Agreement to Develop and Commercialize NovaBay's Novel Aganocide Drugs for Major Dermatological Conditions

...ny focused on developing its proprietary and patented Aganocide compounds, first-in-class, novel, synthetic anti-infective product candidates that are bioequivalent to the active antimicrobial molecules generated within white blood cells to treat and prevent a wide range of infections without causing resistance. ...

SemBioSys Genetics Inc. Announces Clinical Results with Plant-Produced Insulin

... SBS-1000 shown to be bioequivalent to Humulin(R) R (recombinant human insulin) ...platform. The trial demonstrated that SBS-1000 was bioequivalent to a recombinant human insulin with the expected s...e preliminary analysis were: - SBS-1000 was bioequivalent to Eli Lilly's Humulin(R) R, a widely-used ...

Strativa Pharmaceuticals Announces Successful Completion of Bioequivalence Studies for Ondansetron Thin Film

...rcialization 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 constitute one of the largest segments of the ...

Viropharma Comments On Upcoming FDA Advisory Committee Meeting

...nfection results in significant morbidity and mortality, and has developed into a national health issue. The risk to patients of a product that is not bioequivalent to Vancocin in this setting is high. "While the notice does not specifically identify Vancocin, ViroPharma intends to take every opportunity to ensu...