After Fentanyl Shortage, FDA Expedites Approval Of ANDA For Teva’s Patch
Executive Summary
FDA expedited approval of Teva's ANDA fentanyl transdermal system after a shortage of fentanyl patches threatened patient access.
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Transdermal patches to get new warnings
FDA is moving to establish uniform warnings on transdermal patches that contain metal after about a half dozen reports of slight burns on patients' skin during MRIs due to heated contents. The agency expects the effort to take several months. One challenge is designing a warning for products designed to be as unobtrusive as possible; placing the phrase "remove before MRI" on the patches is the working idea. Another challenge is that FDA is not entirely sure which patches contain metal - even trace amounts invisible to the eye can cause burns - and of those, how many need updated warnings. It might be that only as few as three or four of the approximately 60 approved patch products need revised labels. Among the products that will be affected is Teva's fentanyl patch, which FDA acknowledged is "missing" a warning. Teva's product received expedited approval last year following a shortage due to recalls by other manufacturers (1"The Pink Sheet," Oct. 27, 2008, p. 32)
Transdermal patches to get new warnings
FDA is moving to establish uniform warnings on transdermal patches that contain metal after about a half dozen reports of slight burns on patients' skin during MRIs due to heated contents. The agency expects the effort to take several months. One challenge is designing a warning for products designed to be as unobtrusive as possible; placing the phrase "remove before MRI" on the patches is the working idea. Another challenge is that FDA is not entirely sure which patches contain metal - even trace amounts invisible to the eye can cause burns - and of those, how many need updated warnings. It might be that only as few as three or four of the approximately 60 approved patch products need revised labels. Among the products that will be affected is Teva's fentanyl patch, which FDA acknowledged is "missing" a warning. Teva's product received expedited approval last year following a shortage due to recalls by other manufacturers (1"The Pink Sheet," Oct. 27, 2008, p. 32)