Dr. Reddy's failed to provide persuasive, objective evidence that it has a "reasonable apprehension" of being sued by Pfizer for infringing a Zoloft (sertraline) patent, a Newark, N.J. federal judge rules July 7. The court dismissed Reddy's action seeking a declaratory judgment that its ANDA will not infringe Pfizer's '699 patent, which expires on Sept. 28, 2010. Reddy's filed an ANDA with a Paragraph IV certification against the '699 patent, but Pfizer did not sue within the 45 days following notification. The court rejected Reddy's arguments that Pfizer's infringement lawsuit against first ANDA filer Ivax on the '699 patent provides a reasonable basis for believing that Reddy's ultimately would be sued. Pfizer and Ivax settled their litigation in 2002, and the settlement "allows Ivax to begin marketing its generic sertraline product at the end of the expiration of" the compound patent in June 2006, the court said...
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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 US FDA says its release of complete response letters for products subsequently approved by the agency is just a first step toward releasing rejection letters when they are issued, assuming legal issues can be resolved.
The FDA's recent announcement of plans to expand unannounced inspections at ex-US facilities should put firms on advance notice that their next foreign facility inspection may not be preannounced, Ivy Sweeney, acting head of the agency's drug inspections office said.
New US FDA drugs center director George Tidmarsh’s data-centric comments at a Reagan-Udall Foundation meeting on unapproved fluoride products could suggest patients’ and caregivers’ experiences will carry less weight in benefit-risk decisions under his leadership.
