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02.09.2010 Anti-Cancer Agent, Xeloda®
Filed for Advanced or Refractory Gastric Cancer By “New Drug
Application Based on Evidence in the Public Domain” |
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Chugai Pharmaceutical
Co., Ltd. [Head Office: Chuo-ku, Tokyo;
President: Osamu Nagayama (hereafter, "Chugai")]
announced today that
it filed on September 1, a “new drug application
(NDA) based on evidence in the public domain”
with the Japanese Ministry of Health, Labour and
Welfare (MHLW), seeking approval for the
indication “advanced or refractory gastric
cancer in patients who are not candidates for
curative surgery” for the anti-cancer agent
capecitabine (brand name: Xeloda®
Tablet 300, hereafter, “Xeloda®”). In
Japan, Xeloda® is currently marketed
for the indications of “inoperable or recurrent
breast cancer,” “postoperative adjuvant
chemotherapy for colon cancer,” and “advanced or
refractory colorectal cancer in patients who are
not candidates for curative surgery.”
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04.08.2010 "ACTEMRA®"
Humanized Anti-Human IL-6 Receptor Monoclonal
Antibody Conditions for Approval (All Patients
Surveillance) Lifted in Japan |
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Chugai Pharmaceutical
Co., Ltd. [Head Office: Chuo-ku, Tokyo;
President: Osamu Nagayama (hereafter, "Chugai")]
announced today that
it has received a notification from the Japanese
Ministry of Health, Labour and Welfare(MHLW)
that the conditions for approval (surveillance
of all patients*1) are lifted with
“rheumatoid arthritis(RA)” and "polyarticular-course
juvenile idiopathic arthritis (pJIA)"
indications for the humanized anti-human IL-6
receptor monoclonal antibody, ACTEMRA®.
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21.06.2010
Designated for Priority
Review by Ministry of Health, Labour and Welfare |
Chugai Pharmaceutical
Co., Ltd.
[Head Office: Chuo-ku, Tokyo;
President: Osamu Nagayama (hereafter, "Chugai")]
announced today that the Japanese Ministry of Health, Labour and
Welfare (MHLW) designated trastuzumab (genetical recombination), a
humanized monoclonal antibody (brand name: Herceptin®
for Intravenous Infusion 60 and 150, hereafter “Herceptin®”)
as a priority review subject on May 18, following an application
filed on March 19, 2010 with the MHLW seeking additional approval
for the treatment of HER2-positive advanced or recurrent gastric
cancer.
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18.06.2010 Recombinant Human Erythropoietin, “EPOGIN® Subcutaneous
Injection Syringe 24000,” Approved in Japan |
Chugai Pharmaceutical
Co., Ltd.
[Head Office: Chuo-ku, Tokyo;
President: Osamu Nagayama (hereafter, "Chugai")]
announced today that the company has acquired
the marketing approval for “the autologous blood
transfusion of patients who are scheduled with
blood donation of 800 mL or more for their own
surgery with more than one-week blood collection
period (hereafter, the autologous blood
transfusion)” of a recombinant human
erythropoietin (brand name “Epogin®
Subcutaneous Injection Syringe 24000)” from the
Ministry of Health, Labour and Welfare on June
18, 2010.
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