FDA Follows 483 to Omega Nutrition with Warning Letter
Omega Nutrition U.S.A. received an FDA warning letter in early April, which reiterated concerns cited during a December 2010 GMP (good manufacturing practice) inspection and 483 report, as well as product claims used on labels and in marketing. FDA inspectors visited Omega Nutrition’s manufacturing facility in Bellingham, Wash., in early December 2010, and issued a […]
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Baxter Announces the Acquisition of Prism Pharmaceuticals
-Baxter International Inc. (NYSE:BAX) announced today that it has entered into a definitive agreement to acquire privately-held Prism Pharmaceuticals, Inc., a specialty pharmaceutical company based in King of Prussia, PA. Prism Pharmaceuticals has developed and received U.S. Food and Drug Administration (FDA) approval for multiple presentations of NEXTERONE® (amiodarone HCl), an antiarrhythmic agent. The NEXTERONE […]
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Pharma manufacturing ‘best bet’ for college grads: Report
GlaxoSmithKline is sweetening the pot for top-notch UK college grads seeking a career in big pharma. It’s offering to pay select graduates as much as $44,000 in tuition fees for joining GSK’s “post-graduate” training program and then working at the big pharma for the next two years. Through the tuition payment program, GSK targets the […]
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FDA takes another look at cancer drug shortage
FDA is brokering a deal to keep supplies of a leukemia drug available to U.S. patients. It’s been working with Hospira, APP Pharmaceuticals and the Bedford Labs division of Boehringer Ingelheim, producers of the FDA-approved cytarabine that have been hamstrung in producing the parenteral due to scarcity of API. In addition, some supplies of finished […]
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Tissue Genesis Begins FDA-Approved Clinical Trial
Tissue Genesis Begins FDA-Approved Clinical Trial First FDA Cell Therapy Trial Using Adipose Tissue, Collected at Point of Care with an Automated System Tissue Genesis, Inc., an emerging leader in adult stem cell and regenerative medicine, announced today that it has begun clinical trials for peripheral vascular disease (PVD) with adipose (fat) derived adult stem […]
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Consumer Group Calls for Ban on Alli, Xenical Diet Pills
For the second time in 5 years, Public Citizen, a consumer advocacy group, has issued a petition to the U.S. Food and Drug Administration (FDA) calling for the removal of the class of drugs known as orlistat, prescription brands Alli and Xenical diet pills, from the marketplace. The FDA rejected the Public Citizen’s request to […]
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Roche receives FDA approval for SJIA drug
Roche has received the US Food and Drug Administration (FDA) approval for Actemra to treat active systemic juvenile idiopathic arthritis (SJIA) in patients aged two years and older. According to Roche, the FDA’s decision was supported by the positive results from a randomized, double-blind, Phase III study which demonstrated that 85% of children with SJIA […]
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Generic Prevacid Dissolving Problems Lead to Market Withdrawal
Federal regulators are warning that a generic version of the heart burn drug Prevacid, which is supposed to dissolve when suspended in liquid, may clog feeding tubes and oral syringes because it is failing to dissolve properly. The drug has been withdrawn from the market, but hospitals and pharmacies are not being asked to return […]
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Topamax Weird Smell Triggers Johnson & Johnson Recall
An unusual odor has resulted in the recall of 57,000 bottles of Topamax (topiramate) 100mg tablets, an anticonvulsant (antiepilepsy) drug by Ortho-McNeil Neurlogics Division of Ortho-McNeil-Janssen Pharmaceuticals, part of Johnson & Johnson. Two lots have been recalled, involving 57,000 bottles of the medication. However, the company informs that no more than 6,000 bottles are in […]
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FDA issues warning letter to Fresenius SE over dialysis tubing set
The U.S. Food and Drug Administration has issued a warning letter to Fresenius SE for unauthorized design changes to its CombiSet True Flow Series Hemodialysis Blood Tubing Set, marketed by Fresenius Medical Care North America. May 11 Top Selling Webinar – FDA Expectations of Senior Management Save 50% Now with Offer Code 1012199 According to […]
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