Gilead Sciences, Inc.
Gilead Receives Response From U.S. FDA on Company’s Request for Formal Dispute Resolution for Aztreonam for Inhalation Solution
Published in Medical Device Law Weekly, March 8th, 2009
Gilead Sciences, Inc. (Nasdaq:GILD) announced that the company has received a response from the U.S. 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...
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