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Latest From NuPathe, Inc.
US FDA's Search For Meaning: Interpretation Of Regulatory Language Can Inspire Conflict In Drug Reviews
The Pink Sheet's Drug Review Profile series illustrates the challenge of reconciling review realities and broad statutory directives.
Teva CEO Erez Vigodman said the company will step away from business development for the “foreseeable future” while it digests the acquisition of Allergan’s generic drug business.
FDA worries about burning and scarring with the battery-powered Zecuity patch prompted NuPathe to reconfigure the drug-device combo; our Drug Review Profile shows how FDA thought the problem was solved, but adverse reaction reports soon after launch led to marketing suspension.
Fate of migraine patch remains uncertian after 'large number' of patients suffer burns and scars; adverse event was issue during review of transdermal sumatriptan product, but didn't even make it into labeling; nine months later the problems have forced Teva to suspend marketing.