Gilead Sciences, Inc has received a response from the US Food and Drug Administration (FDA) to its appeal, submitted under the formal Dispute Resolution process, regarding the Agency's Complete Response Letter for its New Drug Application (NDA) for aztreonam for inhalation solution.
Gilead initiated the formal Dispute Resolution process in November 2008, following receipt of the Complete Response Letter in September 2008. In its review under the Dispute Resolution process, the FDA reiterated its position outlined in the Complete Response Letter, including the need for Gilead to conduct an additional clinical study of aztreonam for inhalation solution before the company can resubmit its NDA.
Gilead has two ongoing clinical studies evaluating aztreonam for inhalation solution. The company has not yet discussed with the FDA whether or not either of these studies would be sufficient to address the FDA's requirements or whether Gilead will need to design and conduct a new study. The company will provide further updates once it has more clarity regarding timelines.
Aztreonam for inhalation solution is an antibiotic candidate for people with cystic fibrosis who have P aeruginosa.
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