Tag Archives: U.S. Food and Drug Administration

Caraco Pharma Eliminates 350 Jobs

By George Koroneos | Published: July 8, 2009
Caraco Pharmaceutical Labs announced on Monday that it will eliminate half its workforce—approximately 350 positions—but added that the number could grow as the generics firm deals with a voluntary manufacturing shutdown stemming from an FDA investigation. Last month, US marshalls seized an undisclosed amount of drug ingredients and products in a raid at the company’s Michigan [...]
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Chantix and Zyban Get Boxed Warnings

By George Koroneos | Published: July 1, 2009
Image via Wikipedia FDA announced yesterday afternoon that the smoking cessation drugs Chantix (varenicline) and Zyban (bupropion) must bear black box warnings for serious mental health symptoms, including changes in behavior, hostility, depression, and attempted suicide. In addition to being used in smoking cessation, buproprion is also marketed as an atypical antidepressant under the brand name Wellbutrin, [...]
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FDA Panel Calls for Ban on Narcotic/Tylenol Combo Drugs

By George Koroneos | Published: July 1, 2009
Image via Wikipedia A joint committee of three FDA advisory groups voted on Tuesday to recommend the elimination of prescription combination drugs containing acetaminophen due to a spike in instances of liver-induced toxicity. The panel of experts, physicians, and regulators voted 20 to 17 in favor of banning acetaminophen combo drugs such as Vicodin and Percocet. They [...]
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The True Cost of Investigator Compensation

By George Koroneos | Published: May 27, 2009
As government continues to push for physician/pharma payment transparency, and regulations come to pass forcing pharma to disclose how much it gives doctors, one wonders when someone will look into payments to clinical trial investigators? Cutting Edge Information reached out to 58 pharma companies engaged in US-based payments to investigators, and requested post-study data from completed [...]
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Amylin Drops 200 Sales Reps

By George Koroneos | Published: May 6, 2009
Image via Wikipedia Biotech firm Amylin, on Monday, announced that it would trim its sales force by 200, or about 35 percent of its total. The move is expected to save the company about $65 million by 2010, and comes on the heels of an announcement that the company asked FDA to consider a once-weekly injectable [...]
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