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Otsuka is again urging a federal judge in Maryland to prevent the FDA from granting any ANDA for generic versions of Abilify, after the agency indicated this week it had not yet decided whether the blockbuster antipsychotic drug’s exclusivity bars generic approvals. Read More
Brandmaker AbbVie and generics firm Teva are facing a second lawsuit over accusations they illegally delayed generic competition on the cholesterol medication Niaspan. Read More
Drugmakers should summarize medication errors that don’t result in adverse reactions in periodic safety update reports and in their risk-management plans, the European Medicines Agency says. Read More