Regulatory Updates
Date
Product
Update
2024
Feb 15, 2024
Product
Sugammadex Sodium
Update
CADIFA
Feb 15, 2024
Product
Tafamidis
Update
US DMF
Jan 15, 2024
Product
Clascoterone
Update
US DMF
2023
Dec 27, 2023
Product
Fluticasone Furoate
Update
US DMF
Oct 19, 2023
Product
Dasatinib Anhydrous
Update
CADIFA
Oct 01, 2023
Product
Edoxaban Tosylate
Update
CA DMF
Oct 01, 2023
Product
Rivaroxaban
Update
CADIFA
Aug 25, 2023
Product
Tucatinib
Update
US DMF
Jul 01, 2023
Product
Eltrombopag Olamine
Update
Brazil DMF
Apr 01, 2023
Product
Valsartan Sacubitril
Update
US DMF
Feb 01, 2023
Product
Sugammadex Sodium
Update
CN DMF
2022
Dec 20, 2022
Product
Tafamidis
Update
US DMF
Nov 14, 2022
Product
Edoxaban Tosylate
Update
EU DMF
Aug 28, 2022
Product
Memantine HCl
Update
CADIFA
Feb 08, 2022
Product
Ivosidenib API
Update
US DMF
2021
Dec 29, 2021
Product
Eltrombopag Olamine
Update
EU DMF
Dec 14, 2021
Product
Elagolix
Update
US DMF
Nov 01, 2021
Product
Sugammadex Sodium
Update
CA DMF
Sep 13, 2021
Product
Tigecycline
Update
CEP
Jun 13, 2021
Product
Zoledronic acid
Update
CEP
May 01, 2021
Product
Nilotinib Fumarate
Update
EU DMF
2020
Nov 29, 2020
Product
Midostaurin
Update
US DMF
Nov 29, 2020
Product
Ribociclib Succinate
Update
US DMF
Aug 11, 2020
Product
Tacrolimus
Update
CEP
Aug 11, 2020
Product
Aripiprazole
Update
CEP
Jul 02, 2020
Product
Crisaborole
Update
US DMF
May 31, 2020
Product
Caspofungin Acetate
Update
New Korea DMF is available
Feb 02, 2020
Product
Icatibant Acetate
Update
New Canada DMF for Icatibant Acetate is available.
Jan 21, 2020
Product
Sugammadex Sodium
Update
Brazil DMF
Jan 15, 2020
Product
Cabazitaxel
Update
New Canada DMF is available.
2019
Jul 01, 2019
Product
Sugammadex Sodium
Update
US DMF
Apr 11, 2019
Product
Diroximel Fumarate
Update
New US DMF is available.
Mar 20, 2019
Product
Cinacalcet HCl
Update
New China DMF is avaliable.
Feb 14, 2019
Product
Brexpiprazole
Update
New US DMF is available.
Feb 11, 2019
Product
Caspofungin Acetate
Update
New Brazil DMF is available.
2018
Dec 27, 2018
Product
Rivaroxaban
Update
New EU DMF is available.
Dec 25, 2018
Product
Dasatinib Anhydrous
Update
New Canada DMF is available.
Aug 16, 2018
Product
Pregabalin
Update
New Japan DMF is available.
Jul 30, 2018
Product
Micafungin Sodium
Update
New DMF is available.
May 27, 2018
Product
Ezetimibe
Update
New China DMF is available.
Apr 26, 2018
Product
Clopidogrel Bisulfate
Update
New Korea DMF is available.
Apr 26, 2018
Product
Clopidogrel Bisulfate
Update
New REU DMF is available.
Mar 27, 2018
Product
Rivaroxaban
Update
New Canada DMF is available.
Mar 27, 2018
Product
Rivaroxaban
Update
New US DMF is available.
2017
Aug 20, 2017
Product
Dasatinib Monohydrate
Update
New EU DMF is available.
Jun 25, 2017
Product
Ibrutinib
Update
US DMF is available.
May 28, 2017
Product
Montelukast Sodium
Update
New US DMF dated 04/2017 is available.
May 28, 2017
Product
Rivaroxaban
Update
New BR DMF dated 04/2017 is available.
Apr 25, 2017
Product
Dasatinib Monohydrate
Update
New US DMF dated 04/2017 is available.
Apr 25, 2017
Product
Macitentan
Update
New US DMF dated 03/2017 is available.
Apr 25, 2017
Product
Montelukast Sodium
Update
New Korea DMF dated 03/2017 is available.
Mar 28, 2017
Product
Afatinib Dimaleate
Update
New DMF is now available for reference on the FDA website.
Feb 19, 2017
Product
Bortezomib
Update
New Japan DMF dated November 2016 is available.
Jan 05, 2017
Product
Cabazitaxel
Update
New EU DMF dated 12/2016 is available.
Jan 03, 2017
Product
Dasatinib Anhydrous
Update
New EU DMF dated 12/2016 is available.
2016
Dec 19, 2016
Product
Fulvestrant
Update
New IN DMF dated 12/2016 is available.
Nov 15, 2016
Product
Febuxostat
Update
New RU DMF dated 10/2016 is available.
Nov 15, 2016
Product
Pregabalin
Update
New US DMF dated 11/2016 is available.
Sep 25, 2016
Product
Dimethyl Fumarate
Update
New US DMF dated 08/2016 is available.
Sep 25, 2016
Product
Dimethyl Fumarate
Update
New EU DMF dated 09/2016 is available.
Sep 25, 2016
Product
Febuxostat
Update
New CA DMF dated 09/2016 is available.
Jun 29, 2016
Product
Ticagrelor
Update
New KO DMF dated 06/2016 is available.
Jun 27, 2016
Product
Apixaban
Update
New US DMF dated 06/2016 is available.
Jun 27, 2016
Product
Febuxostat
Update
New CA DMF dated 06/2016 is available.
Jun 27, 2016
Product
Icatibant Acetate
Update
New US DMF for Icatibant Acetate dated 6/2016 is available.
May 26, 2016
Product
Imatinib Mesylate
Update
New CEP dated 05/2016 is available.
Apr 25, 2016
Product
Perampanel
Update
New US DMF dated 04/2016 is available.
Mar 13, 2016
Product
Linaclotide
Update
New US DMF dated 03/2016 is available.
Mar 09, 2016
Product
Abiraterone Acetate
Update
New EU DMF dated 02/2016 is available.
Feb 18, 2016
Product
Aripiprazole
Update
New JP DMF dated 02/2016 is available.
Feb 09, 2016
Product
Ulipristal Acetate
Update
New EU DMF dated 01/2016 is available.
Jan 31, 2016
Product
Carfilzomib
Update
New US DMF dated 01/2016 is available.
Jan 25, 2016
Product
Gemcitabine HCl
Update
Recently we have received approval in Taiwan.
Jan 25, 2016
Product
Medroxyprogesterone acetate
Update
Recently we have received approval in Taiwan.
Jan 25, 2016
Product
Olanzapine
Update
Recently we have received approval in Taiwan.
Jan 25, 2016
Product
Oxaliplatin
Update
Recently we have received approval in Taiwan.
Jan 25, 2016
Product
Pravastatin Sodium
Update
Recently we have received approval in Taiwan.
Jan 25, 2016
Product
Simvastatin
Update
Recently we have received approval for Simvastatin ACNBHT (1.16) in Taiwan.
2015
Nov 18, 2015
Product
Pregabalin
Update
New DMF was approved in Korea.
1970
Jan 01, 1970
Product
Tafamidis
Update