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Vancocin in Medical News

ViroPharma Shares Fall As FDA Moves Towards Generic Vancocin

Speculation that the Food and Drug Administration will give a nod for the generic version of Vancocin caused shares in ViroPharma to dip by about 33 percent. The rumors of the FDA's changed perspective // strengthened after Laura Alvey, a spokeswoman for the F.D.A said in an e-mail message that the...

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

... Vancocin(R) (vancomycin hydrochloride) capsules. vancocin is used to treat severe, often life-threatening ba...nt safety must be a primary concern. About vancocin vancocin is the only approved product to treat Clostridium...

ViroPharma Incorporated Reports Second Quarter 2009 Financial Results

...s compared to $65.4 million and $116.4 million for vancocin only in the comparative three and six month period...r of 2009 as compared to 2008 due to a decrease in vancocin sales, increased SG&A costs related to the lau...ghts Our net product sales are related to vancocin and Cinryze. During the second quarter of 2009, w...

ViroPharma Announces Meeting of FDA Advisory Committee for Pharmaceutical Science and Clinical Pharmacology on Bioequivalence Recommendations for Oral Vancomycin Hydrochloride Products

...//www.fda.gov/ohrms/dockets/ac/acmenu.htm . vancocin is the only approved product to treat Clostridium... the OGD's in vitro approach to bioequivalence for vancocin will occur. There can be no assurance that the FDA...ll agree with the positions stated in ViroPharma's vancocin related submissions or that ViroPharma's efforts t...

ViroPharma Provides Update on Vancocin(R)

...e quantities as Vancocin. For generic versions of vancocin that are not Ql and Q2 the same as vancocin with respect to inactive ingredients, FDA is recom...dered for use in approving generic formulations of vancocin that does not require rigorous scientific methods ...

ViroPharma Incorporated Reports Third Quarter 2008 Financial Results

...ed investments in our European operations, our vancocin sales force, additional medical education acti...low and profitability achieved. Net sales of vancocin were $65.9 million for the third quarter of 2008 a...ficer. "As demonstrated by the record net sales of vancocin during the third quarter of the year, the need for...

ViroPharma Incorporated Reports First Quarter 2008 Financial Results

...Net sales of Vancocin(R) achieved $51 million; -- vancocin direct sales efforts commenced; and -- Research a...t guidelines which highlight the recommendation of vancocin for treating patients with severe disease based up...al trial data that demonstrated the superiority of vancocin in this patient population." Net income in the f...

ViroPharma Incorporated Reports Fourth Quarter and Full Year 2007 Financial Results

...welve months ended December 31, 2007, net sales of vancocin increased 24.0 percent and 22.3 percent, respectiv... decreased levels in 2006. The cost of sales for vancocin for the three months ended December 31, 2007 remai...dered for use in approving generic formulations of vancocin that does not require rigorous scientific methods ...

Vincent J. Milano to Succeed Michel de Rosen as President and Chief Executive Officer of ViroPharma

...rward to leading ViroPharma through its next stages of success," commented Vincent Milano. "I firmly believe in the value of our pipeline products and vancocin for patients. Michel has been a great leader for our company during his tenure as well as a great mentor and friend to me. The many successes we have ...

ViroPharma Provides Update on Vancocin(R)

...iroPharma believes the OGD's actions regarding vancocin are illustrative of larger systemic problems a...ased biowaiver to establish bioequivalence for vancocin results in an acceptable level of risk to pati...dered for use in approving generic formulations of vancocin that does not require rigorous scientific methods ...
Vancocin in Medical Technology

Optimer Pharmaceuticals Presents Results From Fidaxomicin Phase 3 Study for the Treatment of Clostridium difficile Infection

...erienced a reduction in CDI recurrence compared to vancocin (p=0.004) and had a higher global cure (cure with no recurrence within four weeks) compared to vancocin (p=0.006). "This study showed that fidaxomici...teristics. Clinical cure rates for fidaxomicin and vancocin were similar in each of the following subgroups: p...

ViroPharma Submits Comments on Vancocin(R) Draft Bioequivalence Guidance

...ocin(R) (vancomycin hydrochloride capsules). vancocin is the only approved product to treat Clostridium...iated complications of the disease can be deadly. vancocin is also approved to treat enterocolitis caused by ... vitro dissolution test because it concluded that vancocin was a "rapidly dissolving" drug product. In Decem...
Vancocin in Biological Technology

Optimer Pharmaceuticals Reports Second Quarter 2009 Financial Results

...erienced a reduction in CDI recurrence compared to vancocin (p=0.004) and had a higher global cure (cure with no recurrence within four weeks) compared to vancocin (p=0.006). Clinical investigator, Mark A. Mi...l demonstrated a lower recurrence rate compared to vancocin (p=0.004) regardless of albumin levels, WBC count ...

Optimer Pharmaceuticals Announces Lower Recurrence Rates for Fidaxomicin Versus Vancocin(R) in Subgroup Analyses from Its Phase 3 Study for the Treatment of CDI

...ll as for patients with non-BI (NAP1/027) strains. vancocin is currently the only FDA approved therapy for CDI... mg fidaxomicin dosed orally twice daily or 125 mg vancocin dosed orally four times daily. This study was cond...ious (non-inferior) and safe as a 10-day course of vancocin (vancomycin hydrochloride capsules, USP) for the t...

ViroPharma Incorporated Reports First Quarter 2009 Financial Results

...t quarter of 2009 as compared to $50.9 million for vancocin only in the first quarter of 2008, representing 18...lights Our net product sales are related to vancocin and Cinryze. As of March 31, 2009, we have $1.8 m...ing the quarter ended March 31, 2009, net sales of vancocin increased 5.1 percent compared to the same period ...

ViroPharma Improves Financial Position Through Repurchase of $45 Million Principal Amount of Senior Convertible Notes

... in which the FDA make a decision regarding either our citizen petition for vancocin or the approval of generic versions of Vancocin; our ability to execute a s...maceuticals and technological advances to treat the conditions addressed by vancocin or Cinryze. Currently our market capitalization is less than our book value...

ViroPharma Incorporated Reports Fourth Quarter and Full Year 2008 Financial Results

...d strong financial performance." Net sales of vancocin were $50.0 million for the fourth quarter of 2008 ...lion. This guidance assumes no generic versions of vancocin are approved in 2009 and excludes any revenue guid...cal development programs, the effectiveness of our vancocin and Cinryze sales efforts, our estimates of future...

ViroPharma Provides Update on Upcoming FDA Advisory Committee Meeting to Discuss Bioequivalence of Locally Acting Gastrointestinal Drugs

...fice of Chief Counsel, ViroPharma will not discuss vancocin at this meeting. Given ViroPharma's experience in ...uct a public process on bioequivalence methods for vancocin specifically. ViroPharma is prepared to participat...lopment of bioequivalence methods specifically for vancocin should include (1) public proposal of the method a...

Viropharma Comments On Upcoming FDA Advisory Committee Meeting

...patients of a product that is not bioequivalent to vancocin in this setting is high. "While the notice does ....viropharma.com/OGDpetition/ ), bioequivalence for vancocin is deserving of "at least the same level of proces...tainties, including the Company's plans to discuss vancocin and the serious disease that Vancocin treats and t...

ViroPharma Provides 2008 Outlook

...ng in both medical education for CDI and promoting vancocin to drive growth for the product; Obviously, the de...dered for use in approving generic formulations of vancocin that does not require rigorous scientific methods ...ll agree with the positions stated in ViroPharma's vancocin related submissions or that ViroPharma's efforts t...
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