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)

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

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.