Fluoxetine will have six months of pediatric exclusivity beginning Feb. 2 when Lilly's patent no. 4,314,081 expires. The additional exclusivity is based on clinical data in adolescents aged seven to 17 from two pediatric depression studies, an obsessive compulsive disorder study and a pharmacokinetic study submitted to FDA. If Lilly is granted a rehearing in appeals court or a review in the Supreme Court for its invalidated Prozac patent (No. 4,626,549), which would have expired in 2004, it could delay Barr's 180 days of Waxman/Hatch exclusivity for generic fluoxetine (1"The Pink Sheet" Oct. 30, p. 14)
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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.’
PharmaMar has voluntarily withdrawn its marketing authorization application for Aplidin to treat multiple myeloma in the EU – almost a decade after it first filed the drug for EU approval and following years of court proceedings.
Antibiotics that tackle antimicrobial resistance are to be automatically included in Italy’s Innovative Medicines Fund, which is designed to provide quick access to innovative medicines.
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.
