Vanda Not Ready To Give Up On Jet Lag Indication For Hetlioz Despite CRL
Complete response letter follows July deficiencies letter that made approval seem highly unlikely. Vanda called the setback perplexing and said it plans to continue working to get jet lag disorder added to the Hetlioz label.
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Vanda May Go Another Round With US FDA Over Hetlioz Jet Lag Indication
Agency offers Vanda chance to request a hearing over its plan to refuse to approve its supplemental new drug application. Such a hearing seems unlikely given FDA’s rejection of past requests and Vanda’s track record with the agency.
Vanda Sues US FDA For Documents Backing Complete Response For Hetlioz Jet Lag Indication
FOIA exemption does not apply to medical and statistical reviews of its sNDA, company claims. It says it needs the information to adapt its development program and determine if the agency made an error.
Keeping Track: US FDA Clears Two More Biosimilars, First Non-Injectable Glucagon
The latest drug development news and highlights from our US FDA Performance Tracker.