Noven's resubmitted Daytrana NDA to be reviewed by April 9

By Lisa Kerner

Erie, Pa., March 10 - Noven Pharmaceuticals, Inc. said the Food and Drug Administration is expected to complete its review of the resubmitted New Drug Application for Daytrana (methylphenidate transdermal system) by April 9.

The resubmission is intended to address the issues presented by the FDA in a December approvable letter, including proposed revisions to labeling, requests for data clarification, post-marketing surveillance and post-marketing studies.

The New Drug Application was resubmitted in February, and the FDA declared it to be a complete Class I response to its approvable letter in March, according to a company news release.

Daytrana, licensed globally to Shire plc, is a developmental product for the treatment of attention deficit hyperactivity disorder in children aged 6 to 12 years, the company said.

Upon FDA approval of Daytrana, Noven would be entitled to receive a $50 million milestone payment from Shire and could earn additional milestone payments of up to $75 million based on Shire's commercial sales of the product, as well as profits on product manufacturing and supply.

Miami-based Noven develops transdermal drug delivery technologies and prescription transdermal products.

Shire is a pharmaceutical company based in Basingstoke, England, that develops products in the areas of central nervous system, gastrointestinal, renal diseases and human genetic therapies.

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