The increase in both depreciation and amortization is primarily due to the inclusion of a full year's amortization and depreciation charge in respect of assets acquired through the TKT acquisition, together with the amortization of capitalized milestone payments for DAYTRANA
following its launch in June 2006.
continues to bring important benefits to patients with ADHD, and sales of the product by Shire in the second quarter triggered the third and final $25 million milestone to Noven," said Brandt.
The addition of DAYTRANA
, combined with the ADDERALL XR market share has helped Shire grow its total share of the US ADHD market to 28% at March 31, 2007 compared to 27% (which included a 1% share relating to ADDERALL) at March 31, 2006.
The depreciation and amortization charge for the year will be approximately 30% higher than the 2005 charge reflecting the acquisition of TKT and the amortization of milestone payments for DAYTRANA
(prior guidance: 50% higher); and
The level of quarterly R&D expenditure is expected to increase over the Q2 2006 spend as we commence phase 3(b)/4 studies to support new product launches (including DAYTRANA
, FOSRENOL and MESAVANCE);
In both the phase II and phase III studies, DAYTRANA
was generally well tolerated during both the dose optimization and double-blind phases.
Because this voluntary recall is not due to product safety issues, all DAYTRANA
patches, including those in the lots listed above, can continue to be used unless the release liner cannot be removed, or the patches are damaged while being opened.
The gain on sale of product rights also included the gain on re-measurement of the contingent consideration receivable relating to the divestment of DAYTRANA
The FDA reviewed 51 cases of chemical leukoderma associated with the Daytrana
patch (methylphenidate transdermal system) reported to the FDA Adverse Event Reporting System (FAERS) database and described in the medical literature from April 2006 to December 2014.
(methylphenidate transdermal system), the first and only patch approved for the treatment of ADHD.
The ruling applies to 15 products: Adderall tablets, Adderall XR extended-release capsules, Concerta extended-release tablets, Daytrana
transdermal system, Desoxyn tablets, Dexedrine Spansule capsules and tablets, Focalin tablets, Focalin XR extended-release capsules, Metadate CD extended-release capsules, Methylin oral solution, Methylin chewable tablets, Ritalin tablets, Ritalin SR sustained-release tablets, Ritalin LA extended-release capsules, and Strattera capsules.
offers true all-day therapy," asserts Noven Pharmaceuticals Vice-President Joseph Jones (Noven manufactures Daytrana
for Shire, plc).
is a once daily treatment containing the drug methylphenidate, a central nervous system (CNS) stimulant.
Basingstoke-based Shire revealed the US Food and Drug Administration had approved Daytrana
as a treatment for attention deficit hyperactivity disorder.
Food and Drug Administration (FDA) for DAYTRANA
(methylphenidate transdermal system), an investigational transdermal patch formulation for methylphenidate designed for once-daily use to treat attention deficit hyperactivity disorder (ADHD) in children aged 6 to 12 years.