Zydus Lifesciences on Monday said it has received an approval from the Drug Controller General of India (DCGI) for Oxemia (Desidustat), a first-of-its-kind oral treatment for anaemia associated with chronic kidney disease (CKD).
The Subject Expert Committee (SEC) has recommended permission to Cadila Healthcare Ltd (Zydus Cadila) to manufacture and market Desidustat tablets, the new oral drug for treatment of anaemia due to chronic kidney disease (CKD), subject to a few conditions. Zydus Cadila has announced in November last year, that it has submitted the New Drug Application (NDA) to the Drug Controller General of India for the drug.
AHMEDABAD, India, Jan. 25, 2021 /PRNewswire/ -- Zydus, a leading discovery based global pharmaceutical company today announced that it has received positive results from Phase 2(b) studies of Desidustat in COVID-19 patients [ClinicalTrials.gov Identifier: NCT04463602] conducted at Mexico.
Zydus announced that it has received approval from the USFDA, to initiate clinical trials of Desidustat in Chemotherapy Induced Anemia (CIA).
Zydus, a leading discovery based global pharmaceutical company, has received approval from the regulatory authority of Mexico, COFEPRIS, for its one of its lead research candidate desidustat to be tested in the management of COVID-19.
Zydus inks pact with China Medical System to market Desidustat in Greater China
Zydus Cadila, an innovation-driven, global pharmaceutical company, announced the Phase III trials of Desidustat, an Investigational New Drug targeted at treating anemia in non-dialysis dependent chronic kidney disease (NDD-CKD) patients.