Dear Community,
I hate to bring the news that the appeal for the Gilead Sciences' Aztreonam Lysine for Inhalation (AZLI) was not approved by the FDA.
Gilead had appealed the original decision not to approve the drug.
With the approval of this drug would have come the FDA approval for the e-Flow nebulizer also.
We received this news with a personal call from Gilead thanking all the members of our site who have supported them through this process.
Gilead promises to continue their Expanded Access Program and is committed to working with the FDA on the additional trials needed.
Sadly,
Jeanne
I hate to bring the news that the appeal for the Gilead Sciences' Aztreonam Lysine for Inhalation (AZLI) was not approved by the FDA.
Gilead had appealed the original decision not to approve the drug.
With the approval of this drug would have come the FDA approval for the e-Flow nebulizer also.
We received this news with a personal call from Gilead thanking all the members of our site who have supported them through this process.
Gilead promises to continue their Expanded Access Program and is committed to working with the FDA on the additional trials needed.
Sadly,
Jeanne