Dr. Reddy's will launch an "authorized" generic version of GlaxoSmithKline's migraine treatment Imitrex (sumatriptan) in the fourth quarter of 2008, according to a patent-infringement settlement agreement announced by the companies Oct. 10. Settlement of the patent litigation allows for earlier entry of a generic version of Imitrex; the suit related to GSK's patent no. 5,037,845, which has pediatric exclusivity extending through February 2009. The agreement also allows India-based Dr. Reddy's to exclusively distribute generic Imitrex in the 25, 50 and 100 mg strengths. GSK filed the patent infringement suit against Dr. Reddy's in December 2003 after the company submitted an ANDA seeking approval of sumatriptan. A 50-mg dose of sumatriptan (marketed by GSK as Imigran Recovery) was approved for nonprescription "Pharmacy" sale by the UK's Medicines & Healthcare products Regulatory Agency in May (1"The Tan Sheet" May 22, 2006, p. 3). GSK is also working with its partner Pozen toward a mid-2007 launch of a next-generation Rx migraine medicine Trexima, combining sumatriptan with naproxen...
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
The inclusion of investigational drugs in the Critical Medicines Act and new provisions on stockpiling are among the raft of amendments the European Parliament has made to the draft legislation.
A meeting between the European Commission and industry stakeholders has revealed several areas of importance and lessons learned in relation to the EU Health Technology Assessment Regulation, which began to apply to certain medicinal products this year.
The US FDA’s unprecedented publication of 89 recent CRLs for unapproved products comes with a promise to release future letters more promptly.
