News Tagged ‘ANDA

FDA should have acted faster to prevent contamination

Leslie Fullerton provided the best care he could for his 29-month-old daughter Natalie with the medical equipment and medications provided him, but he still blames himself for her death. The little girl had already undergone a double-lung transplant and was recovering nicely when her father, following instructions of his daughter’s health care provider, used a pre-filled syringe to clean the tube implanted in Natalie’s chest to give her intravenous medication. Days later, Natalie became breathless and feverish as a bacteria infected her blood. Months later, Natalie died.

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FDA clears Baxter in deaths following heparin injections

syringe 100x100Baxter Healthcare Corp. has been cleared by the Food and Drug Administration () in the deaths of two patients at a Delaware hospital following an injection of the drug maker’s heparin. The attributed the two deaths, and the illness of a third patent, to existing medical conditions. All three patients suffered intercranial bleeding following injections of heparin.

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New deaths, illness following heparin use spark FDA investigation

The Food and Drug Administration () is testing batches of the heparin after two people died and one became ill after receiving doses of the heparin, according to the Wall Street Journal.

All three incidences occurred at the Beebe Medical Center in Lewes, Delaware, and all three were given supplied by Baxter, the same drug company at the center of last year’s contaminated heparin scandal. That , which killed more than 80 people and injured hundreds more, was manufactured in . The latest batch was manufactured in Ohio.

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Obama’s pick for FDA commissioner wants to restore trust in agency

President Barack Obama’s top pick for Food and Drug Administration () commissioner, Bioterrorsim expert and former New York City health commissioner Dr. Margaret Hamburg, says that she wants to restore public confidence in the , according to Boston.com.

She already has Senator Edward M. Kennedy’s support. “Her expertise is valuable for problems we now face, such as combating food-borne illness, cooperating with other agencies to address the new flu outbreak and drug-resistant diseases, and protecting our food and drug supplies,” Sen. Kennedy said in a statement for the Health, Education, Labor, and Pensions Committee hearing.

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FDA approval for marketing generic Lovenox expected

The expiration of exclusivity period for Sanofi Aventis’ Lovenox has expired, moving Momenta Pharmaceutical Inc. one step closer to gaining approval from the Food and Drug Administration () 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 heparin in patients undergoing abdominal surgery.

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Congressman demands answers on tainted heparin scandal

rep joe barton 100x100Rep. Joe Barton of Texas wants the Food and Drug Administration () 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.

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FDA accuses Chinese companies of lying about role in heparin scandal

The Food and Drug Administrating () 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.

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FDA panel recommends agency approval of heparin alternative

blood cells 100x100A Food and Drug Administration () advisory panel voted last week to recommend agency approval of experimental rivaroxaban, according to Forbes. The medication, made by Johnson & Johnson and Bayer Healthcare Pharmaceuticals, is designed to be used on a short-term basis to prevent pulmonary embolism and deep-vein thrombosis in patients having total knee or hip replacement surgery. Blood clots are common after such surgeries.

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Hamburg, Sharfstein to head troubled FDA

The Obama administration has named two doctors to head up the much-criticized U.S. Food and Drug Administration (), individuals who are known for speaking out about public safety. Sources say Margaret Hamburg, a physician and former New York City health commissioner, was selected to run the agency with Joshua Sharfstein, of the Baltimore health commission, as her chief deputy, according to The Washington Post.

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Lawmakers debate safety of importing drugs

Congress continues to debate the notion of allowing people to buy inexpensive drug from other countries, as the Obama administration is encouraging, but the stickler seems to be ensuring the safety of those imported drugs, according to Portfolio.

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