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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
In response to congressional pressure, the HHS inspector general will investigate how recent increases in generic drug prices have impacted the Medicaid rebate program and whether those increases exceeded the inflation rate in 2005 through 2014. Read More
The FDA’s Office of Pharmaceutical Quality is developing a new inspection protocol that will focus on expert investigator-developed questions and assessment practices. Read More