Vanda sNDA Deficiencies Preclude Certain Reviews: FDA

Vanda Pharmaceuticals says it has received FDA notification about undisclosed deficiencies that “preclude discussion of labeling and postmarketing requirements/commitments” involving a supplemental NDA for Hetlioz (tasimelteon) for treating jet lag disorder. FDA stated that the notification does not reflect a final decision on the information under review. The user fee review action target date is 8/16.

Vanda says that Hetlioz was shown to be well tolerated prior to its first approval by FDA in 2014 for Non-24-Hour Sleep-Wake Disorder. “In addition, Vanda has studied Hetlioz for almost 15 years in different settings and conditions, and Hetlioz has consistently demonstrated robust biological effects and clinical benefits,” it says. Vanda expects to receive additional communications from the agency that will identify specific deficiencies in the sNDA, and plans to work expeditiously to resolve any such deficiencies.