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

December 17, 2018

MIAMI--(BUSINESS WIRE)--Dec 17, 2018--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.

View source version on businesswire.com:https://www.businesswire.com/news/home/20181217005053/en/

CONTACT: Stephanie Lamenta

Noven Pharmaceuticals

305-253-1916

KEYWORD: UNITED STATES ASIA PACIFIC NORTH AMERICA FLORIDA JAPAN

INDUSTRY KEYWORD: HEALTH PHARMACEUTICAL

SOURCE: Noven Pharmaceuticals, Inc.

Copyright Business Wire 2018.

PUB: 12/17/2018 09:00 AM/DISC: 12/17/2018 09:01 AM

http://www.businesswire.com/news/home/20181217005053/en

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