January 18, 2010
To Whom It May Concern
KYORIN Co., Ltd.
5, Kanda Surugadai 2-chome,Chiyoda-ku, Tokyo
Securities Code: 4569; TSE 1st Section

MARKETING APPROVAL FOR "MUCODYNE® DS50%"
KYORIN Pharmaceutical Co., Ltd. (Headquarter: Tokyo, President: Keiji Hirai), a subsidiary of KYORIN Co.,
Ltd. announced today that the Ministry of Health, Labour and Welfare approved "MUCODYNE® DS50%" (INN:L-Carbocisteine), Mucoregulating drug, on January 15, 2010.
Kyorin Pharmaceutical Co., Ltd. first marketed MUCODYNE® Tablets (for adults) in January 1981. Later,Kyorin Pharmaceutical Co., Ltd. released MUCODYNE® Fine Granules 50% (for adults), MUCODYNE®
Syrup 5% (for children), MUCODYNE® Tablets 500 mg (for adults) and MUCODYNE® DS（Dry Syrup）
33.3% (for both adults and children) as additional formulations of MUCODYNE® to meet the needs of patientsand medical workers. Kyorin Pharmaceutical Co., Ltd. has also obtained indications for drainage in chronicsinusitis and drainage in otitis media with effusion*1 after initial marketing in Japan.
MUCODYNE® DS 50%, for which Kyorin Pharmaceutical Co., Ltd. gained manufacturing and marketing
approval on the date given above, is a formulation developed by improving MUCODYNE® DS 33.3%,
which is already on the market. This formulation is expected to not only reduce patient dosage but also attenuate
the burden on medical workers by simplifying prescription volume conversion at dispensing points.
Kyorin Pharmaceutical Co., Ltd. will continue to step up its contribution to the treatment of respiratory,
otolaryngological and other diseases with this latest acquisition of manufacturing and marketing approval for
MUCODYNE® DS 50%, in addition to continuing to provide the latest information on the MUCODYNE® ,including findings through the PEACE Study*2.

*1 Kyorin Pharmaceutical Co., Ltd. has obtained indications for exudative otitis media for MUCODYNE®
Syrup and MUCODYNE® DS only.
*2 「 Preventive Effect on Acute Exacerbation of Chronic Obstructive Pulmonary Disease(COPD) withCarbocisteine 1500mg/day」

For Further information, Contact:
KYORIN Co., Ltd.
Management Planning Department
Telephone: +81-3-3293-3414
Fax: +81-3-3293-3454

＜Product Profile for MUCODYNE® DS 50%＞PRODUCT NAME MUCODYNE® DS50%
INN

L-Carbocisteine

INDlCATIONS

For adults
Expectoration for the following diseases: Upper respiratory inflammation (pharyngitis,Laryngitis), acute bronchitis, bronchial asthma, chronic bronchitis, bronchiectasis andpulmonary tuberculosis. Drainage in chronic sinusitis.
For children
Expectoration for the following diseases: Upper respiratory inflammation (pharyngitis,layngitis), acute bronchitis, bronchial asthma, chronic bronchitis, bronchiectasis andpulmonary tuberculosis. Drainage in chronic sinusitis. Drainage in otitis media witheffusion.

DOSAGE ANDFor adults

ADMINISTRATION For oral use, the usual dose for adults is 500 mg of L-carbocisteine (1.0g ofMUCODYNE® DS50%) three times daily. MUCODYNE® DS50% should be suspended
immediately before use. The dose may be adjusted according to age and symptoms.
For children
For oral use, the usual dose for children is 10 mg/kg of L-carbocisteine (0.02g/kg ofMUCODYNE® DS50%) three times daily. MUCODYNE® DS50% should be suspended
immediately before use. The dose may be adjusted according to age and symptoms.
NHI PRICENot listed

PACKAGING

Boxes of 120 packets (1.0g×120 packets)
Bottles of 100 g, and bottles of 500 g.

Underlined sections correspond to changes from MUCODYNE® DS 33.3%.
Reference: Indicated use and marketing launch for each MUCODYNE formulation
Formulations
For adults
For children
Marketing launch
Date of initial marketing in Japan: July 2001○－MUCODYNE® Tablets* Marketed in January 1981 under the name of250mg
MUCODYNE® Tablets
Date of initial marketing in Japan: October 1996○－MUCODYNE® Tablets
500mg
Date of initial marketing in Japan: November 1987○－MUCODYNE® Fine
Granules 50%
Date of initial marketing in Japan: October 1987－○
MUCODYNE® Syrup 5%
MUCODYNE® DS 33.3%○○

MUCODYNE® DS 50%○○

Date of initial marketing in Japan: October 2001
* Scheduled to be discontinued after a fixed period
following the release of MUCODYNE® DS
50%
Date of initial marketing in Japan:
Not yet determined