For Immediate Release
Company name: DAIICHI SANKYO COMPANY, LIMITED
Representative: Joji Nakayama, President and Representative Director
(Code no.: 4568, First Section, Tokyo, Osaka and Nagoya Stock Exchanges)
Please address inquiries to Toshiaki Sai, General Manager,
Corporate Communications Department
Telephone: +81-3-6225-1126
http://www.daiichisankyo.com/
Daiichi Sankyo Receives Approval in Japan for Additional Indication of Rifadin(R) Capsules for Nontuberculous Mycobacterial Disease
Tokyo, JAPAN(May 20, 2011) –Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced today that it received approval in Japan for a supplemental New Drug Application (NDA) for an additional indication of Rifadin® (rifampicin) 150 mg capsules for nontuberculous mycobacterial disease including those caused by Mycobacterium avium and M. intracellulare.
A preliminary evaluation was conducted on November 29 at the meeting of the Second Committee on New Drugs of the Pharmaceutical Affairs and Food Sanitation Council, and the application*1 was permitted, which led Daiichi Sankyo to submit the NDA for an additional indication for Rifadin in December.
Rifampicin formulations, including Rifadin, have previously been approved for the NTM indication and are used as standard treatments overseas.
As a part of its CSR effort, Daiichi Sankyo is committed to making unapproved and off-label drugs available to patients who are waiting for them to be approved.
*1 Application for a drug commonly known to be medically and pharmaceutically safe and with proven efficacy for which clinical trials can be partly or entirely omitted.
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