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Shire Takes The Route Of Least Resistance Into Europe With Approved Oral ADHD Drug

This article was originally published in The Pink Sheet Daily

Executive Summary

Specialty pharma withdraws marketing application for Noven’s Daytrana patch after regulators request European study, sticks with in-licensed oral drug that’s already approved.

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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)

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)

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