Tag Archives: FDA

Takeda Changes Dexlansoprazole Brand Name From Kapidex to Dexilant

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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Margaret Hamburg Uncovered

Judging by the lack of movement on the RSS feeds, most pharma companies gave their employees the day off to celebrate Martin Luther King Day. So, as defacto Pharm Exec photo editor, I thought it might use this quiet time to show off some outtakes from our recent photo shoot with FDA Commissioner Margaret Hamburg, [...]
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FDA Readies More Warning Letters, Fast Enforcement Action

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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Adverse Event Reports Go Digital Only

Image via Wikipedia FDA, this morning, walked media through its proposed regulations requiring that pharma companies submit post-market adverse event reports through an electronic format. This is being done to help eliminate time and cost wasted on paper submissions. “This change will enhance FDA’s ability to rapidly identify new safety concerns and share safety information with [...]
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Woodcock Under Investigation

Image by Getty Images via Daylife An FDA director has come under fire by a generics firm claiming that the director of the Center for Drug Evaluation and Research favored a competitor in a wanton act of conflict of interest. The Wall Street Journal this morning broke the story that Janet Woodcock is under investigation by [...]
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