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  • Regulatory NewsRegulatory News

    Antipsychotic Label Updated With New Impulse-Control Side Effects

    • 03 May 2016
    • By
    The US Food and Drug Administration (FDA) on Tuesday warned that compulsive or uncontrollable urges to gamble, binge eat, shop and have sex have been reported with the use of Otsuka’s antipsychotic drug aripiprazole (brand names include Abilify, Abilify Maintena, Aristada) or generic versions from Alembic Pharmaceuticals, Hetero Labs, Teva Pharmaceuticals and Torrent Pharmaceuticals. “These uncontrollable urges were reported to have stopped when the medicine was disconti...
  • Regulatory NewsRegulatory News

    FDA Accepts for Review First NDA for a 'Digital' Medicine

    The US Food and Drug Administration (FDA) has accepted for review what is being considered the first new drug application (NDA) for a combination product to include a sensor embedded into the tablet. The developer of the sensor – Proteus Digital Health – said it could help improve patient medication adherence and better inform physician decision-making to tailor treatments to the patient's needs. In the case of this new drug application, the sensor is paired with Otsuka...
  • NICE Plans to Recommend Abilify for Treatment of Bipolar Disorder in Children

    The UK's National Institute for Health and Care Excellence (NICE) has issued draft guidance proposing to recommend aripiprazole (Abilify, Otsuka Pharmaceuticals Europe), for treating moderate to severe manic episodes in adolescents aged 13 and older with bipolar I disorder. In 2006, NICE published clinical guidelines on the overall management of bipolar disorder in adults, children and adolescents, noting concerns that "the evidence for drug and psychological treatm...