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Category Archives: Labeling

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European Commission Seeking Comments on Draft Text Laying Out the Safety Features to Appear on Pharmaceutical Packaging

Posted in Drugs, European Union, Labeling

EU building (vertical)On 12 August 2015, the European Commission published its long awaited discussion draft of the European Union Delegated Act (EUDA) addressing safety features to appear on the outer packaging of medicinal products for human use. The EUDA was a response … Continue Reading

Otsuka Files Amended Complaint and Motion for TRO/PI for Abilify®, Pointing to Congressional Intent to Argue Broad Exclusivity

Posted in Drugs, Labeling, Litigation, Rare Diseases

antibioticsAs discussed in our April 13, 2015 blog, Otsuka Pharmaceutical Co., Ltd. Otsuka Pharmaceutical Development and Commercialization, Inc., and Otsuka America Pharmaceutical, Inc. (collectively “Otsuka”) had until April 15, 2015 to file an amended complaint and a temporary restraining … Continue Reading