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  5. 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

June 27, 2014

Otsuka Pharmaceutical Co., Ltd.

Pharmaceuticals

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 June26 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.

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