Posts Tagged ‘FDA’« Older Entries
From our good friends at the FDA:
Following actions by the Food and Drug Administration (FDA), a Texas-based company has agreed to recall and destroy a dietary supplement linked to dozens of cases of acute liver failure and hepatitis, including one death and illnesses so severe that several patients required liver transplants.
In addition to the recall of certain OxyElite Pro products, USPLabs assured FDA officials that it will destroy warehouse stocks of the supplement, with a retail value of about $22 million. FDA will oversee the destruction of the product.
“As soon as we suspected a possible link between OxyElite Pro products and cases of liver failure and non-viral hepatitis in Hawaii, we warned the public and immediately launched an investigation with state officials and the Centers for Disease Control and Prevention (CDC),” said Daniel Fabricant, Ph.D., director of FDA’s Division of Dietary Supplement Programs. “Our mandate to protect the public was fulfilled by ensuring the swift removal of the product from the marketplace.”
FDA used new enforcement tools provided by the FDA Food Safety Modernization Act to act quickly in the face of a potential danger to public health.
The supplement was advertised as an aid to losing weight and building muscles. FDA warned the company on Oct. 11, 2013, that certain OxyElite Pro products and another supplement, VERSA-1, are considered adulterated because they contain a new dietary ingredient, aegeline, for which the company did not provide evidence of safety.
While FDA’s investigation is still ongoing, the agency continues to warn consumers to avoid using OxyElite Pro and VERSA-1.
Earlier this year, a stockpile of another formulation of OxyElite Pro was destroyed after being held through an FDA administrative detention order. A stimulant included in those products, DMAA, or dimethylamylamine, can cause high blood pressure and lead to heart attacks, seizures, psychiatric disorders and death.
After removing DMAA from its products, USPLabs substituted aegeline, among other ingredients, in certain OxyElite Pro products. Non-synthetic aegeline is an alkaloid extract from leaves of the Asian bael tree (Agele marmelos).
“Twice in a short period, this company has added new dietary ingredients to supplements without notifying the FDA and providing a reasonable expectation of safety, as required by law,” said Fabricant. “Losses to the company should also serve as a reminder that FDA’s laws and regulations serve a purpose and must be followed.”
On October 22, 2013, the FDA reported that Reser’s Fine Foods of Beaverton, OR was recalling approximately 109,000 cases of refrigerated ready-to-eat products because it may be contaminated withListeria monocytogenes. The recalled refrigerated ready-to-eat products were distributed nationwide and Canada.
It reported: NO illnesses have been reported to date.
On October 24, 2013, the FDA reported that Boston Salads and Prepared Foods of Boston, MA was voluntarily recalling prepared salads, because they have the potential to be contaminated with Listeria monocytogenes. Product was distributed throughout the MA, CT, RI, VT, and ME states to wholesale and food service distributors, and retail stores.
It reported: There has been no illness or complaints related to this recall.
On October 25, 2013, the FISS reported that Garden Fresh Foods of Milwaukee, WI was recalling approximately 103,080 additional pounds of ready-to-eat chicken and ham products due to possible contamination with Listeria monocytogenes. The company was recalling these products in addition to the 25,748 pounds of similar products that were recalled on Sept. 25 and Oct. 17, 2013.
It reported: FSIS and the company have not received reports of illnesses due to consumption of these products.
On October 25, 2013, the FSIS reported that Taylor Farms of Jessup, MD was recalling approximately 5,084 pounds of broccoli salad kit products. The kits contain salad dressing in packets that were the subject of a Food and Drug Administration (FDA) recalldue to concerns about possible Listeria monocytogenes contamination. The salad kits were shipped to distributors and retail locations (delis) for consumer purchase in Connecticut, Delaware, Maryland, Massachusetts, New Jersey, New York and Vermont.
It reported: FSIS, FDA and the company have received no reports of illnessesassociated with consumption of these products.
On October 26, 2013, the FSIS reported that Reser’s Fine Foods of Topeka, KS was expanding its recall of chicken, ham and beef products to include all products produced between Sept. 5 and Oct. 9, 2013. This was in addition to the 22,800 pounds of product recalled on Oct. 22, 2013. The products are being recalled due to possible contamination with Listeria monocytogenes.
It reported: FSIS and the company have not received reports of illnesses due to consumption of these products.
Then on October 26, 2013 the FDA reported that Reser’s Fine Foods of Beaverton, OR was voluntarily expanding its October 22, 2013 recall of refrigerated ready-to-eat products because they may be contaminated with Listeria monocytogenes. The recalled refrigerated ready-to-eat products were distributed nationwide and Canada.
Then it changed the wording regarding illnesses to: There are no confirmed illnessesassociated with these products.
Illnesses linked to the above recalls or not?
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Pharma & Healthcare – The latest on Sun Pharma shares, Valeant Settlement, and more.
Shares of Sun Pharmaceutical Industries Ltd(SUN.NS) fell as much as 2.1 percent after Bloomberg News reported the drug maker had received queries from the U.S. Food and Drug Administration over quality control at a U.S. subsidiary.
Sun received two so-called Form 483s, issued when the U.S. regulator has queries, for its Detroit-based Caraco Pharmaceutical Laboratories Ltd following inspections in January and May this year, Bloomberg reported on Monday, citing a Freedom of Information Act request… [ Read More ]
Valeant Pharma to pay Anacor $142.5M in settlement by Bloomberg Business Week on Bloomberg Business Week
NEW YORK (AP) — Valeant Pharmaceuticals will pay Anacor Pharmaceuticals $142.5 million in a settlement, the companies said Monday.
The payment will be made by Nov. 8, and it will resolve all disputes between Anacor and Valeant. That includes legal proceedings involving Medicis Pharma, which Valeant acquired in December.
Anacor says that Dow Pharmaceutical Services, which is now part of Valeant, breached a contract related to Anacor’s work on Jublia. The drug is a treatment for onychomycosis, a fungal infection of the nail and nail bed. On Oct. 18 an arbitrator awarded Anacor $100 million in damages and ordered Valeant to pay costs and attorney’s fees as well. Anacor, of Palo Alto, Calif., said it believed it had other claims against Valeant as well… [ Read More ]
Is It Pharma’s Fault That We Don’t Have Better Drugs For Malaria, TB And Tropical Diseases? by John LaMattina on Forbes
“Despite some high-profile commitments from some of the industry’s largest innovators, R&D for some of the world’s most deadly neglected diseases remains underfunded and unimpressive, according to a study, a state of affairs that has barely improved over the last three decades.”
So starts an article by Damian Garde of FierceBiotech. Garde is referring to a recent paper in “The Lancet” entitled: “The drug and vaccine landscape for neglected diseases (2000 -11): a systematic assessment.” Neglected diseases are defined as diseases that affect people in low-income countries and are the leading cause of mortality, chronic disability and poverty. They include malaria, tuberculosis, diarrheal diseases, and tropical diseases. The Lancet paper made the following points… [ Read More ]
Sun Pharma says issues with USFDA at Caraco facility addressed by The Economic Times
NEW DELHI: Drug maker Sun Pharmaceutical today said it has addressed the US health regulator’s concerns about manufacturing lapses at its US-based Caraco Pharmaceutical Laboratories. United States Food and Drug Administration had conducted inspections in January and May this year and had noticed the lapses.
When asked about the nature of lapses and the corrective measures the company has taken a Sun Pharmaceutical spokesperson said they were “minor observations”.
“The company has responded to these a long time back,” the spokesperson said without elaborating. Earlier in the August 2012, Sun Pharmaceutical Industries had said American health regulator had approved resumption of manufacturing operations at Caraco for two drugs after inspections of facilities… [ Read More ]
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Press Release from FDA, Released on 09/20/2013
Today, the U.S. Food and Drug Administration announced a final rule for the unique device identification system (UDI) that, once implemented, will provide a consistent way to identify medical devices.
The UDI system has the potential to improve the quality of information in medical device adverse events reports, which will help the FDA identify product problems more quickly, better target recalls, and improve patient safety. The FDA has worked closely with industry, the clinical community and patient and consumer groups in the development of this rule.
“UDI represents a landmark step in improving patient safety, modernizing our postmarket surveillance system for medical devices, and facilitating medical device innovation,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.
The UDI system consists of two core items. The first is a unique number assigned by the device manufacturer to the version or model of a device, called a unique device identifier. This identifier will also include production-specific information such as the product’s lot or batch number, expiration date, and manufacturing date when that information appears on the label…. [ Read More ]
When: Tuesday, November 05 to Wednesday, November 06, 2013
Where: Millennium Knickerbocker Hotel, Chicago, IL
To Learn More, Visit: www.americanconference.com/fdabootcamp-devices
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Pharma & Healthcare – the latest on DEA probe, False Claims Act, Pfizer and more.
Costco says cooperating with DEA probe on controlled substances by Jessica Wohl Editing by Leslie Adler and Bob Burgdorfer Posted on Reuters
Costco Wholesale Corp (COST.O) said on Wednesday that it will cooperate with the U.S. Drug Enforcement Administration in its ongoing investigation of prescriptions for controlled substances, after receiving subpoenas and warrants from the DEA. The DEA has targeted large pharmacy chains and distributors to stem the flow of prescription drugs where abuse is suspected… [ Read More ]
Supreme Court Considering False Claims Act Appeal by Brian Mahany Posted on jdsupra.com
The Supreme Court is considering an appeal from the 4th Circuit regarding the specificity necessary when pleading false claims act cases. The issue has serious implications for whistleblowers who can only document indirect frauds against government programs… [ Read More ]
Early Promise in Drug Trial for Fighting Cholesterol by Andrew Pollack Posted on the NYTimes.com
A new type of lipid-lowering drug being developed by Sanofi and Regeneron Pharmaceuticals cut cholesterol levels by about half in its first late-stage clinical trial, the companies will announce on Wednesday. The drug, called alirocumab, is one of a new class of potentially powerful cholesterol fighters that have excited doctors and investors alike, spurring a heated race to market among Sanofi, Amgen, Pfizer and other companies… [ Read More ]
Pfizer gets European approval for label update of pneumococcal conjugate vaccine Prevenar 13 by pharmaceutical-technology Posted on pharmaceutical-technology
Pfizer has received European Commission approval for updates to the summary of product characteristics (SmPC) for its pneumococcal conjugate vaccine (PCV) Prevenar 13, regarding its use in certain high-risk populations. The updated label now contains information about the use of Prevenar 13 in preterm infants, children and adolescents with sickle cell disease who were earlier treated with the 23-valent pneumococcal polysaccharide vaccine…[ Read More]
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Pharma & Healthcare – the latest on FDA approval, Sanofi, Biotech drugs, and more.
Maine Goes Rogue on Importing Prescription Drugs by Megan McArdle Posted on Bloomberg.com
Maine has decided to allow importing of prescription drugs from countries that control the prices of said drugs. The result will be a discount for Maine residents, some decrease in the incentives and money for drug discovery and, eventually, some sort of government or private action that shuts down this gambit. Maine is not the first U.S. state government that has decided it would be nice to run its own trade policy… [ Read More ]
Gov. Brown of California Vetoes Biotech Drug Bill by ANDREW POLLACK Posted on NYTimes.com
The first year of skirmishes in state legislatures over bills that would govern the use of cheaper versions of expensive biotechnology drugs is nearly over. Health insurers and generic drug companies have prevailed in most states over brand-name pharmaceutical companies. Their latest victory came in dramatic fashion on Saturday, when Gov. Jerry Brown of California vetoed a bill that had passed both houses of the legislature with overwhelming bipartisan support, but that critics said would limit the use of less expensive drugs… [ Read More ]
Sanofi’s Nasacort Allergy 24HR nasal spray receives FDA approval for over-the-counter use by news-medical.net on news-medical.net
Sanofi announced today that the U.S. Food and Drug Administration (FDA) approved Nasacort® Allergy 24HR nasal spray as an over-the-counter (OTC) treatment for seasonal and year-round nasal allergies in adults and children 2 years of age and older. Nasacort is the first and only medicine in its class to be available without a prescription and will be marketed by Sanofi’s consumer healthcare division, Chattem, Inc. “We believe there is significant value in making certain types of medicines, like Nasacort, directly available to consumers,” said Anne Whitaker, President, North America Pharmaceuticals, Sanofi US. “Allergy sufferers will benefit from having an additional treatment option and it’s a strong addition to our existing consumer health portfolio.” [Read More ]
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Medical-device tax repeal is an idea full of holes Posted on WP Opinions by Editorial Board
F THE Capitol Hill impasse ever ends, it will probably be through a compromise under which House Republicans abandon their demands to delay or defundObamacare — in return for a concession Senate Democrats can tolerate. One scenario involves Republican support for a spending bill in return for repealing one source of funding for the health-care law: a 2.3 percent excise tax on medical devices…. [ Read More ]
Pharmaceutical firms paid to attend meetings of panel that advises FDA Posted on The Washington Post by Peter Whoriskey
A scientific panel that shaped the federal government’s policy for testing the safety and effectiveness of painkillers was funded by major pharmaceutical companies that paid hundreds of thousands of dollars for the chance to affect the thinking of the Food and Drug Administration, according to hundreds of e-mails obtained by a public records request. The e-mails show that the companies paid as much as $25,000 to attend any given meeting of the panel, which had been set up by two academics to provide advice to the FDA on how to weigh the evidence from clinical trials. A leading FDA official later called the group “an essential collaborative effort.” [ Read More ]
Bliss Pharmaceutical company denies FDA allegations Posted on VibeGhana by VibeGhana
Bliss GVS Pharma limited (BLISS), at the weekend dismissed the classification of Food and Drugs Authority (FDA) that products of the company, which are distributed locally by Tobinco Pharmaceuticals Limited are fake. “We will like to state emphatically that all our products have been subjected to stringent quality standards and meet the required accreditations in India. It is unfortunate that the FDA released a statement classifying our products as fake,” a statement issued by the company said… [ Read More ]
Missouri offers tax breaks for pharmaceutical company Posted on BizJournal by Matthew Hibbard
Pharma Medica Research Inc. announced Thursday that it plans to create 320 jobs and invest $30.8 million in the St. Charles region. If the company follows through, the state will dole out more than $4.2 million in tax breaks through the Missouri Quality Jobs program, according to Amy Susan, communications director for the Missouri Department of Economic Development…. [ Read More ]
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October 2nd, 2013
in Pharmaceuticals / Biotech / Life Sciences |
Today, October 1, 2013 marks the beginning of a government’s shutdown for an indefinite period of time. The Food & Drug Administration (FDA) will furlough forty-five percent of its employees on Tuesday, October 2, 2013 as it enacts its contingency plan for the government shutdown. In a document released last week, the Department of Health and Human Services (HHS) broadly outlined its methodology determining which FDA employees and services will be retained or furloughed during the shutdown.
What we know:
- The FDA will retain employees who perform duties that are not affected by the lapse in funding, all presidential appointees, and those positions that are “related to the safety of human life.” Although the agency has not disclosed specific details, HHS has stated that the FDA will continue “limited” programs that are funded by industry fees.
- The agency will retain 587 staff to inspect products and review imports, and an additional staff of 120 to handle emergencies and high-risk recalls. These programs will continue in some capacity because they are “related to the safety of human life.”
- The majority of the FDA’s food safety, nutrition, and cosmetics activities will be suspended.
- The drug review process is likely to slow as the majority of laboratory research will be halted.
- There will also be far fewer routine establishment inspections, enforcement activities, and notification programs.
While the exact impacts of the government shutdown on FDA programs remains unclear, the food and drug industry should expect significant delays and confusion as the agency implements its shutdown contingency plan.Reprinted with permission from Michael Best & Friedrich LLP. © 2013 Michael Best & Friedrich LLP
Top 5 FDA related news articles from last week. Click on the title to read the complete article.
Published on The Packer written by Tom Karst
Published on Capital Press written by Capital Press
Published on North Bay Business Journal written by Loralee Stevens
Published on Nashua Telegraph written by John Bachman
Published on Bloomberg written by Anna Edney
Industry Related: 2nd FDA & USDA Compliance Boot Camp
When: Tuesday, October 01 to Wednesday, October 02, 2013
Where: InterContinental Chicago, Chicago, IL
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Boost your FDA regulatory IQ Learn about the FDA approval process and the ins and outs of post-approval challenges.
When: Tuesday, September 17 to Wednesday, September 18, 2013
Where: Omni Parker House, Boston, MA
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Industry Related News
The first nonhormonal drug to treat hot flashes won approval from the Food and Drug Administration on Friday, offering a new alternative to menopausal women.
The move was surprising because an advisory committee to the F.D.A. voted 10 to 4 in March against approval.The treatment, which will be called Brisdelle, was developed by Noven Pharmaceuticals and consists of a low dose of paroxetine, which is used at higher doses in the antidepressant Paxil.
Approved treatments for menopausal hot flashes until now have all contained the hormone estrogen, sometimes in combination with progestin. But hormone use has decreased sharply since a study in 2002 suggested that the combination of estrogen and progestin could increase the risk of cardiovascular problems and cancer.
“There are a significant number of women who suffer from hot flashes associated withmenopause and who cannot or do not want to use hormonal treatments,” Dr. Hylton V. Joffe, director of the F.D.A’s division of bone, reproductive and urologic products, said in a statement.
While the F.D.A. does not have to follow the recommendations of its advisory panels, it is highly unusual for it to approve a drug that receives a strong negative vote. Committee members who voted against it said while there was a need for a nonhormonal therapy, Noven’s candidate was only minimally effective.
The agency did not explain why it went against the panel’s recommendation, saying only that it viewed Brisdelle as a useful treatment that had met its goals in clinical trials.Women in the clinical trials for Brisdelle started out with a median of about 10 hot flash episodes a day. After 12 weeks, those who took the drug had a median of nearly six fewer episodes a day, compared with a reduction of four or five episodes a day for those receiving the placebo.
While the difference was statistically significant, many members of the advisory committee said such a difference would not be meaningful to women.Noven, which is based in Miami and is a subsidiary of Hisamitsu Pharmaceutical of Japan, said Brisdelle would be available in November. It did not say how much the drug would cost.
Dr. Joel Lippman, chief medical officer of Noven, said in a statement that 24 million women in the United States had moderate to severe hot flashes and that two-thirds of them were not currently treating them.Brisdelle’s label has a strong warning that the drug can increase suicidal thoughts or behavior, language similar to that on the labels of other drugs containing paroxetine. Other warnings include an increased risk of bleeding, and possible reduction in the effectiveness of the breast cancer drug tamoxifen if both drugs are used together.
The advisory panel in March gave an even stronger no vote to another proposed nonhormonal treatment for hot flashes, an extended-release version of the neurology drug gabapentin. In that case, the F.D.A. went along with the panel, rejecting the drug, according to an announcement by its developer, Depomed.