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Recent News and Articles on the Keywords: fda + plavix + use  Related to the article below (Last Update: 12/1/2008)

 News results: Standard Version | Text Version | Image Version Results 1 - 10 of about 132 for fda plavix use. (0.90 seconds) 
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Pharmalot
Viehbacher?s First Day On The Job At Sanofi
Pharmalot, NJ -
Sanofi had pressed ahead with tests on thousands of patients, hoping to win approval as a diabetes treatment, even after an FDA panel last year rejected the ...

eFluxMedia
New study: A Common Class of GI Medications Reduce Protection ...
MarketWatch - Nov 11, 2008
Medco's researchers plan to provide the findings to the Food and Drug Administration (FDA) as part of their recently announced research collaboration in the ...
Heartburn Meds May Interefere With Plavix Pharmalot
all 252 news articles »

The Star-Ledger - NJ.com
UPDATE: Schering Sees 5 New Drug Applications In 2009
CNNMoney.com - Nov 24, 2008
The company is developing it both as a stand-alone drug and a fixed-dose combination with the active ingredient of Plavix, which is the blockbuster ...
Schering-Plough previews drug pipeline The Star-Ledger - NJ.com
Schering-Plough touts pipeline over competitors' The Associated Press
all 85 news articles »  SGP - OTC:SHRGY
J&J's High-Wire Heart Drug
Forbes, NY - Nov 10, 2008
Eli Lilly (nyse: LLY - news - people ) has a new thinner it hopes can replace Plavix, but it has been delayed for months at the FDA for unclear reasons. ...
Rivaroxaban Phase II Dose-Ranging Study Demonstrates Encouraging ... MarketWatch
all 48 news articles »  JNJ
Stock Picks for Healthy Returns
Motley Fool - Nov 25, 2008
... and Eli Lilly (LLY) ? with LLY still waiting on a FDA decision for Effient (prasugrel) to compete with multi-billion dollar blood thinner Plavix. ...
Tailoring clopidogrel loading on the basis of responsiveness ...
TheHeart.Org, NY - Nov 10, 2008
"We could discuss whether 50% is the ideal cutoff, and I would suggest to you that we are still learning how to use these antiplatelet tests; I personally ...
Germany: UPDATE: The German Plavix Case: Loopholes In European ...
Mondaq News Alerts (registration), UK - Nov 12, 2008
In a strict sense, clopidogrel besylate as the API of Clopidogrel YES so far has not been in medicinal use at all in the European Community. ...
A Backlog Of Decisions Is Building At The FDA
istockAnalyst.com (press release), OR - Nov 7, 2008
Promacta was endorsed by an FDA panel for short-term use this past summer and Amgen (AMGN) received FDA approval in late August for Npate as the first ...
Is Lilly's prasugrel safe?
FiercePharma, DC - Nov 12, 2008
... been awaiting FDA approval since it submitted the highly-anticipated medication for review last December. Prasugrel is a direct competitor of Plavix, ...LLY
Pharmaceuticals Industry
Zacks.com, IL - Nov 21, 2008
(BMY) blood-thinner Plavix or Pfizer's anti-cholesterol agent Lipitor because of the credit crunch is the epitome of irrational anxiety. ...PFE - LLY
Source: Google News


 

Recent News and Articles on the Keywords: plavix + fda + 78,700  Related to the article below (Last Update: 8/7/2008)


Wall Street Journal Blogs
Global Generics Rush: Plavix in Germany, Depakote in US
Wall Street Journal Blogs, NY - Jul 30, 2008
Abbott?s Depakote, approved for epilepsy, bipolar disorder and migraines, is now generic in the US, the FDA said. A bunch of generics manufacturers ...
ThromboVision Completes T-Guide(R) Clinical Trials; Files With the ...
MarketWatch - Jul 29, 2008
"With nearly 50 million patients on medications like aspirin and clopidogrel (Plavix(R)) to modify the aggregability of their platelets, we are anxious to ...
Investigational Heart Medicine May Replace Popular Use of Plavix
RedOrbit, TX - Jul 23, 2008
Effient is presently undergoing priority FDA review. A priority designation by the FDA sets the goal date. The goal for priority applications is to have an ...
Handa Pharmaceuticals Announces Submission of its First-to-File ...
MarketWatch - Jul 31, 2008
... Hatch- Waxman Act. Should its ANDA be approved by the FDA, Handa believes that its product will be entitled to 180 days of generic market exclusivity. ...

Sify
Pharma alliances, a shot in the arm
Sify, India - Jul 12, 2008
At the same time, lacking are new blockbusters to replace ones such as Lipitor, Plavix and Zyprexa. Eli Lilly?s anti-blood-clotting drug Prasugrel posted ...OTC:RBXLY - PINK:DSKYF - TYO:4568
Ask Dr. H: A puzzling aspect of age and a swelling prostate
Philadelphia Inquirer, PA - Jul 21, 2008
After the procedure, my doctor placed me on Plavix and aspirin, which I'm still taking. He used coated stents that are supposed to cut my chances of getting ...
Sanofi-aventis News
PharmaLive.com (press release), PA - Jul 31, 2008
In the United States, sales of Plavix(R) (consolidated by Bristol Myers Squibb - BMS) totaled $1208 million in the second quarter of 2008, compared with ...SNY
Bristol-Myers, Eli Lilly post strong 2Q results
The Associated Press - Jul 24, 2008
Plavix posted a 17 percent jump in sales in the quarter, to $1.39 billion, or nearly one-third of Bristol-Myers's total pharmaceutical sales of $4.5 billion ...LLY - BMY
Horizon moving to Chicago; Medivation touts Alzheimer's success;
FierceBiotech, DC - Jul 31, 2008
Release > No cheers at Sanofi-Aventis or Bristol-Myers Squibb today: A German court has paved the way for an immediate launch of generic Plavix. ...

Wall Street Journal
Drug maker Lilly to announce 2Q earnings Thursday
Forbes, NY - Jul 23, 2008
If approved, prasugrel would compete against the blockbuster Plavix, made by Bristol-Myers Squibb Co. (nyse: BMY - news - people ) and Sanofi-Aventis (nyse: ...
Rising Lilly sales, profit meet expectations Indianapolis Business Journal
all 162 news articles »  LLY
Source: Google News

Clopidogrel-Associated TTP An Update of Pharmacovigilance Efforts Conducted by Independent … -
A Zakarija, N Bandarenko, DK Pandey, A Auerbach, … - Stroke, 2004 - Am Heart Assoc
... in a new window], TABLE 1. Completeness and Timeliness of Cases Reported by Independent
Researchers, Pharmaceutical Suppliers of Clopidogrel, and the FDA. ...

Contribution of Hepatic Cytochrome P450 3A4 Metabolic Activity to the Phenomenon of Clopidogrel … -
WC Lau, PA Gurbel, PB Watkins, CJ Neer, AS Hopp, … - Circulation, 2004 - Am Heart Assoc
... Dual antiplatelet therapy (aspirin plus clopidogrel) for acute coronary syndromes
was approved by the FDA in 2002 on the basis of the Clopidogrel in Unstable ...

Clopidogrel-Associated TTP
A Zakarija, N Bandarenko, DK Pandey, A Auerbach, … - Stroke, 2004 - Am Heart Assoc
... in a new window], TABLE 1. Completeness and Timeliness of Cases Reported by Independent
Researchers, Pharmaceutical Suppliers of Clopidogrel, and the FDA. ...

Platelet ADP receptor antagonists: ticlopidine and clopidogrel -
AK Jacobson - Best Practice & Research Clinical Haematology, 2004 - Elsevier
... Clopidogrel has since been approved by the FDA for reduction of thrombotic events
in recent myocardial infarction, stroke or established peripheral arterial ...

Delaying Generic Competition--Corporate Payoffs and the Future of Plavix -
M Shuchman - New England Journal of Medicine, 2006 - content.nejm.org
... According to Apotex court filings, in early 2006, when the company learned that
the FDA would soon approve its generic clopidogrel, it began to produce a large ...

Clopidogrel versus Aspirin and Esomeprazole to Prevent Recurrent Ulcer Bleeding -
FKL Chan, JYL Ching, LCT Hung, VWS Wong, VKS Leung … - New England Journal of Medicine, 2005 - content.nejm.org
... Approval package for application number 20-839/SE1-019 (Plavix). (Accessed December
27, 2004, at http://www.fda.gov/cder/foi/nda/index97.htm); Fork FT, Lafolie ...

Active-control trials: How would a new agent compare with placebo? A method illustrated with … -
LD Fisher, M Gent, HR Buller - American Heart Journal, 2001 - pt.wkhealth.com
... approval of clopidogrel and enoxaparin considered Refludan (lepirudin) at the May
2, 2000, meeting. At this meeting several FDA statisticians expressed concern ...

[PDF] Clopidogrel and thrombotic thrombocytopenic purpura: no clear case for causality -
NS Majhail, AE Lichtin - Cleve Clin J Med, 2003 - ccjm.org
... ed 11 cases of TTP associated with clopidogrel use. This report prompted the US
Food and Drug Administration (FDA) to suggest that a warning about TTP risk be ...
-

[CITATION] FDA Approves New Medical Use for Plavix-Drug benefits Patients with common form of Heart Attack
US Food, D Administration - 2006 - Accessed

[PDF] Clopidogrel now available to treat ACS -
FDA Serono - nursing2006.com
... The FDA has approved Plavix (clopidogrel) to treat acute coronary syndrome
(ACS) without ST- segment elevation, a new indication. ...
-

Source: Google Scholar
 
 

FDA approves expanded use for Plavix

The popular blood-thinning drug Plavix received expanded federal approval Thursday to prevent the sudden blockage of arteries that can lead to heart attack, stroke and death.

The approval means Plavix may be used to treat patients who have had a type of severe heart attack called acute ST-segment elevation myocardial infarction, or STEMI, and who are not going to have angioplasty to clear blocked arteries, the Food and Drug Administration said.

 

The sudden, total blockage of an artery can provoke the type of heart attack. An estimated 500,000 Americans suffer such heart attacks each year, according to the American Heart Association.

In 1997, Plavix, now the world's second best-selling drug, received FDA approval to thin the blood and prevent clots that can block arteries.

The expanded approval comes as Bristol-Myers Squibb Co. and Sanofi-Aventis SA seek a court injunction to block Canadian drug company Apotex Corp. from selling a less expensive, generic version of Plavix. Sales of the drug last year were about $5.9 billion. A court hearing on the motion is set for Friday.

Serious side effects of Plavix, also known as clopidogrel bisulfate, include bleeding and, rarely, low white blood cell counts and low platelet counts with spontaneous bleeding and clotting, the FDA said.

___

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