ATryn(R), GTC's recombinant form of human antithrombin, is in a pivotal clinical study that is anticipated to part of a Biologics License Application
to be filed with the US Food and Drug Administration for the prevention of thromboembolisms in hereditary antithrombin deficient patients undergoing high risk procedures such as surgery and childbirth.
24, 2015 /PRNewswire/ -- Green Cross Corporation (Green Cross), a South Korean biopharmaceutical company, today announced that it has submitted its Biologics License Application for IVIG-SN (human normal immunoglobulin G for intravenous administration) to the United States Food and Drug Administration (FDA).
The FDA has a 60-day filing review period to determine whether Green Cross' Biologics License Application for IVIG-SN is complete and acceptable for filing.
UCB has received a Complete Response Letter from the United States Food and Drug Administration (FDA) requesting additional information and clarification on data submitted in its Biologics License Application
(BLA) for the approval of CIMZIATM in Crohn's disease.
Food and Drug Administration (FDA) has issued a complete response letter regarding the Biologics License Application for belatacept in kidney transplantation.
The Biologics License Application submitted for belatacept included 24-month data from the Phase 3 studies.
A Biologics License Application
is expected to be filed with the FDA in late 2005.
Company Intends to file Biologics License Application in US in 2005
GSK has not filed a biologics license application (BLA) for Fluarix in the US, however, as a result of this year's flu vaccine shortage, Fluarix is now available for use in the United States under the Investigational New Drug regulations.
If the results from these studies are favorable, the company would anticipate filing with the FDA a biologics license application
(BLA) supplement for marketing approval of BioThrax for this indication.
XOMA can rapidly create a production process and advance antibodies into pilot scale production, then complete process scale-up and produce GMP material for use in human clinical trials, Biologics License Applications
filings, and initial commercial launch.
The FDA has recently announced that New Drug Applications, Biologics License Applications
and Efficacy Supplements submitted after June 30, 2006 are required to conform to the SPL-PLR format.