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A Chinese senior health official says China has been unfairly labeled as a center for fake drug production and that blame should be placed instead on foreign companies who do business with unregistered firms against Chinese regulations.
Bian Zhenijia, director of the drug safety supervision department of the State Food and Drug Administration (SFDA), urged companies to be more responsible when dealing with foreign suppliers.
The expiration of exclusivity period for Sanofi Aventis’ blood thinner Lovenox has expired, moving Momenta Pharmaceutical Inc. one step closer to gaining approval from the Food and Drug Administration (FDA) to manufacture and market is generic Lovenox, M-Enoxaparin, according to Momenta’s first quarter 2009 Earnings Call.
Anticoagulants are often administered to patients before undergoing some surgeries and medical procedures to reduce the risk of life-threatening blood clots. Lovenox has been touted as an effective replacement for the blood thinner heparin in patients undergoing abdominal surgery.
Rep. Joe Barton of Texas wants the Food and Drug Administration (FDA) to turn over databases stemming from last year’s tainted heparin scandal that killed more than 80 Americans and injured hundreds more, according to NASDAQ.com. At a public hearing last week, Barton raised concerns that the agency doesn’t know for sure what caused the contamination.
The Food and Drug Administrating (FDA) is accusing two Chinese pharmaceutical manufacturing companies of lying to federal regulators about their role in shipping batches of contaminated heparin into the United States between 2007 and 2008, according to Easy Bourse.
Rep. Joe Barton, a ranking member of the House Energy and Commerce Committee, appears to be fed up with the FDA’s reluctance to provide details of the tainted heparin scandal that first came into public light earlier this year, according to CNN Money. That scandal resulted in the deaths of more than 80 Americans and adverse reactions in hundreds more, and led to an agency recall of lots of the blood thinner manufactured in Baxter International’s Chinese facility.
The Associated Press reported today that Food and Drug Administration Commissioner Dr. Andrew von Eschenbach will resign from his post effective Jan. 20, the same day president-elect Barack Obama takes office.
Von Eschenbach was appointed by President Bush in 2005 after the agency’s previous commissioner resigned due to ethical issues, the AP reports. While under von Eschenbach’s helm, the FDA has undergone scrutiny by Congress and consumer groups over issues such as the tainted heparin scandal earlier this year.
The sole provider of heparin in the United States, APP Pharmaceuticals LLC, has launched a Web site as a first step toward improving the safety of the medications it sells in the U.S., according to Reuters.
The Web site details the safety measures the pharmaceutical company has taken over the past several months, including enhanced labeling, unit-of-use bar codes, large lettering and color-coded bottle stoppers to help eliminate misuse of its products, which also includes injectible drugs for oncology.
A team of researchers from the Massachusetts Institute of Technology (MIT) has confirmed that over-sulfated chondroitin sulfate was, in fact, the contaminant in heparin that was manufactured in China and triggered serious allergic reactions that caused more than 80 Americans to die and hundreds more to be sickened earlier this year, according to ABC Action News.
Researchers have come up with an easy and effective method to detect contaminates in heparin, according to the Times of the Internet. A research team led from the University of Michigan and led by Mark Meyerhoff uses potentiometric polyanion sensors to detect heparin in blood. These sensors also can be used to distinguish pure heparin from heparin contaminated with small quantities of oversulfated chondroitin sulfate.
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