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Transdermal patches to get new warnings

Executive Summary

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)

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Shire recalls Daytrana patches

Shire is voluntarily recalling certain lots of Daytrana (methylphenidate) from the market due to a glitch in the product's release liner removal specifications, which could give patients and caregivers a hard time removing the release liner when they peel the patch. The transdermal patch - the only one indicated for attention deficit/hyperactivity disorder - is manufactured by Noven and licensed globally to Shire. Noven noted that the action was expected and in 2008 the company established a $3.8 million financial reserve for a potential recall. Manufacturing problems have lead to recalls of a number of high-profile patch products over the past year, including leaky fentanyl patches (1"The Pink Sheet," March 9, 2009, In Brief) and UCB's Neupro (rotigotine), which had crystallization problems (2"The Pink Sheet" DAILY, March 21, 2008). UCB also plays a role in the ADHD news; Shire is withdrawing its European application for Daytrana and instead will enter that market with an oral therapy it acquired recently from UCB (3"The Pink Sheet" DAILY, March 13, 2009)

After Fentanyl Shortage, FDA Expedites Approval Of ANDA For Teva’s Patch

FDA expedited approval of Teva's ANDA fentanyl transdermal system after a shortage of fentanyl patches threatened patient access.

Japan Regulators Kept On Track Despite Pandemic

While it was not as affected as some other countries, Japan still had the pandemic to deal with and regulators responded while managing to keep up regular product review work, including several world-first approvals. Coronavirus vaccine roll-outs and the first general annual reimbursement price cut are on the cards for this year. 





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