FDA Denies Gilead’s Appeal Of Aztreonam Lysine “Complete Response” Letter
This article was originally published in The Pink Sheet Daily
Gilead has not yet discussed with FDA whether ongoing studies will be sufficient for resubmission of the inhaled antibiotic for use by cystic fibrosis patients.
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FDA’s complete response letter requesting another trial concludes the agency’s review of an amended NDA submitted after an unsuccessful appeal of a “not approvable” letter.
FDA’s complete response finds the Cayston NDA not approvable as is.
Canadian specialty pharma now awaits new action date for delayed once-daily analgesic, already launched in 12 other countries.