Aztreonam approval delayed

folione · Sep 17, 2008

I think yesterday's letter from FDA was unexpected - my son's Dr. had been talking about it as a done-deal.

"SAN FRANCISCO -- Gilead Sciences Inc. said late Tuesday it received a letter from the Food and Drug Administration informing the company that it cannot approve aztreonam lysine in its current form and an additional clinical study will be required. Gilead had submitted a new drug application for aztreonam lysine for inhalation for people with cystic fibrosis. "Gilead will continue its dialogue with the FDA to determine whether further analyses of existing data could lead to approval, or whether the company will need to conduct the additional study as stated in the letter," said the drug maker."

folione · Sep 17, 2008

I think yesterday's letter from FDA was unexpected - my son's Dr. had been talking about it as a done-deal.

"SAN FRANCISCO -- Gilead Sciences Inc. said late Tuesday it received a letter from the Food and Drug Administration informing the company that it cannot approve aztreonam lysine in its current form and an additional clinical study will be required. Gilead had submitted a new drug application for aztreonam lysine for inhalation for people with cystic fibrosis. "Gilead will continue its dialogue with the FDA to determine whether further analyses of existing data could lead to approval, or whether the company will need to conduct the additional study as stated in the letter," said the drug maker."

folione · Sep 17, 2008

I think yesterday's letter from FDA was unexpected - my son's Dr. had been talking about it as a done-deal.

"SAN FRANCISCO -- Gilead Sciences Inc. said late Tuesday it received a letter from the Food and Drug Administration informing the company that it cannot approve aztreonam lysine in its current form and an additional clinical study will be required. Gilead had submitted a new drug application for aztreonam lysine for inhalation for people with cystic fibrosis. "Gilead will continue its dialogue with the FDA to determine whether further analyses of existing data could lead to approval, or whether the company will need to conduct the additional study as stated in the letter," said the drug maker."

folione · Sep 17, 2008

I think yesterday's letter from FDA was unexpected - my son's Dr. had been talking about it as a done-deal.

"SAN FRANCISCO -- Gilead Sciences Inc. said late Tuesday it received a letter from the Food and Drug Administration informing the company that it cannot approve aztreonam lysine in its current form and an additional clinical study will be required. Gilead had submitted a new drug application for aztreonam lysine for inhalation for people with cystic fibrosis. "Gilead will continue its dialogue with the FDA to determine whether further analyses of existing data could lead to approval, or whether the company will need to conduct the additional study as stated in the letter," said the drug maker."

folione · Sep 17, 2008

I think yesterday's letter from FDA was unexpected - my son's Dr. had been talking about it as a done-deal.
 
 "SAN FRANCISCO -- Gilead Sciences Inc. said late Tuesday it received a letter from the Food and Drug Administration informing the company that it cannot approve aztreonam lysine in its current form and an additional clinical study will be required. Gilead had submitted a new drug application for aztreonam lysine for inhalation for people with cystic fibrosis. "Gilead will continue its dialogue with the FDA to determine whether further analyses of existing data could lead to approval, or whether the company will need to conduct the additional study as stated in the letter," said the drug maker."

Giggles · Sep 17, 2008

My doc has been talking about this drug as a possibility for me down the line too like it was a done deal. Geez! That is discouraging.

Jennifer 36 years old with CF and CFRD

Giggles · Sep 17, 2008

My doc has been talking about this drug as a possibility for me down the line too like it was a done deal. Geez! That is discouraging.

Jennifer 36 years old with CF and CFRD

Giggles · Sep 17, 2008

My doc has been talking about this drug as a possibility for me down the line too like it was a done deal. Geez! That is discouraging.

Jennifer 36 years old with CF and CFRD

Giggles · Sep 17, 2008

My doc has been talking about this drug as a possibility for me down the line too like it was a done deal. Geez! That is discouraging.

Jennifer 36 years old with CF and CFRD

Giggles · Sep 17, 2008

My doc has been talking about this drug as a possibility for me down the line too like it was a done deal. Geez! That is discouraging.
 
 
 Jennifer 36 years old with CF and CFRD

Ratatosk · Sep 17, 2008