Dentifrice line from Den Mat expands with Extra Whitening Fluoride toothpaste in six formulations: original, natural, mint, baking soda, sensitive and canker sore. The new version contains "maximum Citroxain," the company's patented whitening ingredient, to "safely whiten teeth beyond stain removal." The product joins recent toothpaste and mouthwash extensions, introduced in May, along with plans for a $10 mil. ad spend (1"The Tan Sheet" May 1, p. 10)
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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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PharmaMar has voluntarily withdrawn its marketing authorization application for Aplidin to treat multiple myeloma in the EU – almost a decade after it first filed the drug for EU approval and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.