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Notification of a New Drug Application for HP-3070 (Transdermal Patch for the Treatment of Schizophrenia) in the U.S.

Hisamitsu Pharmaceutical Co., Ltd. (Headquarters: Tosu City, Saga Prefecture, President and Chief Executive Officer (CEO): Hirotaka Nakatomi, hereinafter "Hisamitsu Pharmaceutical"), in conjunction with its U.S. subsidiary, Noven Pharmaceuticals, Inc., announces that a New Drug Application has been submitted to the U.S. Food and Drug Administration (FDA) seeking approval of HP-3070 (asenapine) transdermal system for the treatment of schizophrenia (Development code: HP-3070, generic name: asenapine, hereinafter referred to as “the investigational product”).

The investigational product is a systemic transdermal formulation developed using Hisamitsu Pharmaceutical’s Transdermal Drug Delivery System (TDDS) technology. Hisamitsu Pharmaceutical expects the investigational product to be a new option in the treatment of schizophrenia. The development of the investigational product represents Hisamitsu Pharmaceutical’s commitment to improving the lives of the community of patients who live with schizophrenia.

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Last Updated: 17-Dec-2018