topics

Oct,31 2019
New England Journal of Medicine Publishes Results from Astellas’ Phase 3 ADMIRAL Trial of XOSPATA® (gilteritinib) in Adult Patients with FLT3 Mutation-Positive Relapsed/Refractory Acute Myeloid Leukemia
Oct,25 2019
European Commission Approves Astellas’ XOSPATATM (gilteritinib) as a Monotherapy for Patients with Relapsed or Refractory Acute Myeloid Leukemia with a FLT3 Mutation
Sep,24 2019
Astellas Receives Positive CHMP Opinion for XOSPATA® (gilteritinib) as a Monotherapy for Patients with Relapsed or Refractory Acute Myeloid Leukemia with a FLT3 Mutation
Jun,14 2019
Newly-marketed drug
Zonisamide Tablets 100mg EX「KO」
May,31 2019
U.S. FDA Approves Supplemental New Drug Application Adding Overall Survival Data for XOSPATA® (gilteritinib)
–XOSPATA is the only FDA-approved targeted treatment for adult patients with relapsed or refractory FLT3 mutation-positive Acute Myeloid Leukemia
Apr,02 2019
Phase 3 ADMIRAL Trial Data Show XOSPATA® (gilteritinib) Significantly Prolongs Overall Survival in Adult Patients with FLT3 Mutation-Positive Relapsed/Refractory Acute Myeloid Leukemia
–Study results will be presented at AACR2019
Feb,28 2019
Astellas Announces Acceptance of XOSPATATM (gilteritinib) for Regulatory Review by the European Medicines Agency
Feb,09 2019
70th anniversary of foundation.
Dec,14 2018
Newly-marketed drug
RAMATROBAN TAB. 50mg「KO」
RAMATROBAN TAB. 75mg「KO」
LORNOXICAM TAB. 2mg「KO」
LORNOXICAM TAB. 4mg「KO」
Dec,11 2018
Astellas Launches XOSPATA® (gilteritinib) in the U.S. for the Treatment of Adult Patients with Relapsed/Refractory Acute Myeloid Leukemia (AML) with a FLT3 Mutation
Dec,03 2018
Launch of XOSPATA® Tablets 40mg in Japan
Provides a new therapeutic option for patients with AML
Nov,29 2018
XOSPATA® (gilteritinib) Approved by U.S. FDA for Adult Patients with Relapsed/Refractory Acute Myeloid Leukemia (AML) with a FLT3 Mutation
Sep,21 2018
Astellas Announces Approval in Japan for XOSPATA® 40mg Tablets for the Treatment of FLT3mut+ Relapsed or Refractory AML
Aug,15 2018
Receive marketing approval in Japan.
RAMATROBAN TAB. 50mg「KO」
RAMATROBAN TAB. 75mg「KO」
LORNOXICAM TAB. 2mg「KO」
LORNOXICAM TAB. 4mg「KO」
Jun,15 2018
Newly-marketed drug
FLECAINIDE ACETATE TAB. 50mg「KO」
FLECAINIDE ACETATE TAB. 100mg「KO」
May,29 2018
U.S. FDA Grants Priority Review to New Drug Application for Gilteritinib for the Treatment of Adult Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML)
May,22 2018
SUJANU® Combination Tablets released
Drug combining selective DPP-4 inhibitor and selective SGLT2 inhibitor
Apr,24 2018
New Drug Applications for Approval of Gilteritinib for the Treatment of FLT3mut+ Relapsed or Refractory Acute Myeloid Leukemia ware submitted in Japan.
Mar,23 2018
SUJANU® Combination Tablets combining type-2 diabetes drugs receive marketing approval in Japan.
Mar,22 2018
The Japanese MHLW Grants Orphan-Drug Designation for Development of FLT3 Inhibitor Gilteritinib in Acute Myeloid Leukemia.
Feb,15 2018
Receive marketing approval in Japan.
FLECAINIDE ACETATE TAB. 50mg「KO」
FLECAINIDE ACETATE TAB. 100mg「KO」
Jan,23 2018
European Commission Grants Orphan-Drug Designation for Development of FLT3 Inhibitor Gilteritinib in Acute Myeloid Leukemia.
Dec,08 2017
Newly-marketed drug
TORASEMIDE TAB. 4mg「K0」
TORASEMIDE TAB. 8mg「K0」
Oct,11 2017
U.S. FDA Grants Fast Track Designation to Astellas for Development of Gilteritinib in Relapsed or Refractory Acute Myeloid Leukemia.
Jul,21 2017
U.S. FDA Grants Orphan-Drug Designation for Development of FLT3 Inhibitor Gilteritinib in Acute Myeloid Leukemia.
May,22 2017
Submits application for approval of type-2 diabetes drug combining selective SGLT2 inhibitor “Suglat® Tablets” and selective DPP-4 inhibitor “JANUVIA® Tablets” .(Joint development with Astellas Pharma Inc. and MSD )
Jul,01 2014
Hiroshi Tomiyama took office as president.
Apr,17 2014
Newly-marketed drug
Suglat Tablets 25mg
Suglat Tablets 50mg
Dec,13 2013
Newly-marketed drug
DONEPEZIL HYDROCHLORIDE OD TAB. 10mg「KO」
Nov,18 2013
Anticancer drug (ASP2215) (Phase1, development by Astellas Pharma Inc.)
Anticancer drug (ASP5878) (Phase1, development by Astellas Pharma Inc.)
Mar,13 2013
Submits Application for Marketing Approval of Ipragliflozin (ASP1941)/SGLT2 Inhibitor for Treatment of Type 2 Diabetes(Joint development with Astellas Pharma Inc.), in Japan.
Oct,30 2012
We changed development number of cholesterol absorption inhibitor KT6-971 to S-556971.
Nov,28 2011
Newly-marketed drug
Donepezil Hydrochloride OD Tablets 3mg「KO」
Donepezil Hydrochloride OD Tablets 5mg 「KO」
Jun,24 2011
AZULOXA TAB. 15mg and KIRIGAMIL Nasal Solution 50μg 56 mists.It was listed in the drug price list in Japan.
Nov,19 2010
Newly-marketed drug
FENOFIBRATE CAP. 67mg「KTB」
FENOFIBRATE CAP. 100mg「KTB」
Jun,28 2010
That the efficacy and safety of ASP-1941 were validated by the Japanese phase Ⅱb and American Phase IIa was presented at American Diabetes Association.
Mar,22 2010
A lecture was given on KT6-971, a next generation cholesterol absorption inhibitor, at American Chemical Society, which was also featured by New Current 21.
Nov,13 2009
Newly-marketed drug
MARZULENE CONBINATION TABLETS 0.375 ES
Aug,06 2009
American Chemical Society requested us to give a lecture as a guest speaker on KT6-971, a newly developed item, at a session of next generation cholesterol absorption inhibitors.
Apr,06 2009
AZULOXA granules 2.5%, developed by our company,were launched onto the market together with Ajinomoto Co., Inc.
Feb,07 2009
60th anniversary of foundation.