Advertisement
Medexus Pharma Resubmits Treosulfan NDA To FDA
(RTTNews) - Medexus Pharmaceuticals (MDP.TO, MEDXF.OB) and its strategic partner medac announced Monday that medac has resubmitted its New Drug Application (NDA) for treosulfan with the U.S. Food and Drug Administration (FDA).
The current submission was a response to the FDA request to submit information to complete medac's April 2022 NDA resubmission and initiate FDA review.
The NDA requests approval of treosulfan in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation (allo-HSCT).
The current submission includes updates to data files and supporting information in response to the FDA's information request received with the FDA's acknowledgment of receipt of the NDA resubmission in May 2022.
If the response is considered complete by the FDA, the review clock for the NDA resubmission will then start as of the date of submission of a complete response.
For More Such Health News, visit rttnews.com
U.S. Producer Prices Inch Up 0.1% In May, Less Than Expected
U.S. Weekly Jobless Claims Unexpectedly Unchanged At Eight-Month High
Bay Street Likely To Open On Negative Note
U.S. Producer Prices Inch Up Less Than Expected In May
U.S. Weekly Jobless Claims Unchanged At 248,000
Boeing Shares Hit After 787-8 Dreamliner With 242 Onboard Crashes In India
FTSE 100 Recovers After Weak Start, Up Marginally
