Jun 2014

Regulatory Approval Received in Japan For L-Cartin® FF Tablets

Japan

Regulatory Approval Received in Japan For L-Cartin® FF Tablets 100 mg・250 mg Doses That Incorporate Carnitine in Free Form (FF*) Enables Medical Professionals to Conveniently Switch Patients Among the Three Free-Form Formulations – Tablet, Oral Solution and Injection
  • Only Otsuka Pharmaceutical has marketed in Japan the therapeutic agent, L-Cartin® tablets (non- free form) for carnitine deficiencies. L-Cartin free-form (FF) tablets have now been approved as an additional tablet form with the same active ingredient levocarnatine in free form as the oral solution and injection approved in 2013.
  • The new L-Cartin FF tablet was developed with the same active ingredients as the oral solution and injection, mindful of the need among medical professionals for a convenient way to convert patient dosing across the different forms.
  • Carnitine deficiency can occur among people, for example, with congenital metabolic disorders or who are undergoing hemodialysis and symptoms include muscle pain, fatigue, hyperammonemia (elevated ammonia levels in blood) or hypoglycemic coma in severe cases.

Otsuka Pharmaceutical received regulatory approval on June 26 for manufacture and sale of in Japan of L-Cartin Free Form (FF) tablets (generic name levocarnatine) in two doses, 100 mg and 250mg.

  • *FF(free-form) levocarnatine is the unchlorinated form of levocarnatine.

Information in this news release was current as of the original release date.

 

Otsuka Pharmaceutical Co., Ltd. (OPC) is a global healthcare company with the corporate philosophy: 'Otsuka-people creating new products for better health worldwide.' Otsuka researches, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for the treatment of diseases and nutraceutical products for the maintenance of everyday health. 

In pharmaceuticals, Otsuka is a leading firm in the challenging area of mental health and also has research programs for several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate more powerfully than words how Otsuka is a “big venture” company at heart, applying a youthful spirit of creativity in everything it does. 

Otsuka Canada Pharmaceutical Inc. (OCPI) is an innovative, fast-growing health care company that commercializes Otsuka medicines in Canada. OCPI aims to improve the quality of life and health of patients through its commitments to neuroscience, cardiovascular health, oncology and nephrology. OCPI was established in 2010, with headquarters in Saint-Laurent, Quebec.

 

OCPI is part of Otsuka Pharmaceutical Co., Ltd., a wholly owned subsidiary of Otsuka Holdings Co., Ltd., based in Tokyo, Japan. The Otsuka group of companies employed 45,000 people worldwide and had consolidated sales of approximately CAD 14.5 billion (USD 11 billion) in 2016.

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