Category Archives: FDA

Takeda Changes Dexlansoprazole Brand Name From Kapidex to Dexilant

By Oriana Schwindt | Published: March 5, 2010
Takeda’s US subsidiary launched its proton pump inhibitor dexlansoprazole last February under the name Kapidex. No one thought they’d have to find a new name a year later. But shortly after the launch, the company began getting reports of dispensing errors. Some were due to prescription misreading, others to simple, honest mistakes. The two drugs causing [...]
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FDA and GSK on the Hunt for Stolen Drugs

By George Koroneos | Published: February 24, 2010
Image by Johnny Grim via Flickr We typically don’t get emails from FDA  asking for information about stolen goods with massive bold letters, but that’s what just came into our inbox. Looks like a transport truck containing a mix of GlaxoSmithKline’s pharmaceutical and over-the-counter medications was jacked in Puerto Rico on January 29, and the feds [...]
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Health Reform Hazards: Steering Your Course Through the Rhetorical Shallows

By William Looney | Published: December 9, 2009
Image by Getty Images via Dayli Crafting consensus legislation on health reform depends heavily on all parties understanding precisely the terms of the debate. With the two House and Senate bills now topping out at more than 4,000 text pages, prospects for even a basic awareness of the implications of this reform for big pharma and [...]
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Feds Chase Down Faulty Skincare Promos

By George Koroneos | Published: August 26, 2009
FDA’s Division of Drug Marketing Communications, this week, posted a slew of warning and untitled letters to pharma firms for misleading skincare advertisements. Johnson & Johnson, Galderma, and Allergan each received a letter documenting complaints ranging from false advertising to unsubstantial efficacy claims. J&J received a violation letter in response to a journal ad for its [...]
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FDA Readies More Warning Letters, Fast Enforcement Action

By Jill Wechsler | Published: August 26, 2009
Image by Getty Images via Daylife FDA officials have been promising stiffer enforcement of manufacturing and marketing requirements for several months, and commissioner Margaret Hamburg is moving full-speed ahead to fulfill those predictions. Last month, FDA announced it will issue warning letters quickly when it finds violations and will require manufacturers to respond promptly. Too many [...]
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