"Based on current information, we believe that the supply of Soliris to patients will not be interrupted and that the Warning Letter does not restrict production of Soliris or shipment of Soliris from the Rhode Island facility. We continue to manufacture products, including Soliris, in this facility. Additionally, a third party manufacturing facility is currently approved worldwide for production of Soliris. Further, an additional third party manufacturing facility was validated in 2012 for production of Soliris, and we are currently completing our regulatory submissions for this facility. We anticipate first approval for this additional facility to occur in Q4 of 2013. Finally, we estimate that our current inventory of Soliris licensed for commercial sale is sufficient for at least four-thousand patient-years of patient treatment."
"Unless and until we are able to correct outstanding issues to the FDA's satisfaction, the FDA may withhold approval of requests for export certificates for certain countries. The FDA may also withhold approval of pending drug applications listing the Rhode Island facility. We will notify appropriate international regulatory authorities of the Warning Letter, and it is possible that the letter may impact our ability to supply Soliris manufactured at our Rhode Island facility outside the United States."
Avant Technologies Equipping AI-Managed Data Center with High Performance Computing Systems • AVAI • May 10, 2024 8:00 AM
VAYK Discloses Strategic Conversation on Potential Acquisition of $4 Million Home Service Business • VAYK • May 9, 2024 9:00 AM
Bantec's Howco Awarded $4.19 Million Dollar U.S. Department of Defense Contract • BANT • May 8, 2024 10:00 AM
Element79 Gold Corp Successfully Closes Maverick Springs Option Agreement • ELEM • May 8, 2024 9:05 AM
Kona Gold Beverages, Inc. Achieves April Revenues Exceeding $586,000 • KGKG • May 8, 2024 8:30 AM
Epazz plans to spin off Galaxy Batteries Inc. • EPAZ • May 8, 2024 7:05 AM