FDA Accepts HETLIOZ® (tasimelteon) Supplemental New Drug Application for Review in the Treatment of Jet Lag Disorder

WASHINGTON , Dec. 20, 2018 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration ( FDA ) has accepted the filing of Vanda's Supplemental New Drug Application for HETLIOZ ® (tasimelteon) for the treatment of jet lag disorder. The FDA determined the action target date under Prescription Drug User Fee Act (PDUFA-VI), to be August 16 , 2019. HETLIOZ ® is currently approved for the treatment of Non-24 Hour Sleep Wake Disorder. For a review of the current prescribing information of HETLIOZ ® please visit www.hetlioz.com . About HETLIOZ ® (tasimelteon) HETLIOZ ® (tasimelteon) is a melatonin receptor agonist. HETLIOZ ® has been granted market authorization by the U.S. Food and Drug Administration and the European Medicines Agency . For full U.S. prescribing information, please visit www.hetlioz.com . Important Safety Information The most common adverse reactions (incidence >5% and at least twice as high on HETLIOZ ® (tasimelteon) than on placebo) were headache, increased alanine aminotransferase, nightmares or unusual dreams, and upper respiratory or urinary tract infection. The risk of adverse reactions may be greater in elderly (>65 years) patients than younger patients because exposure to HETLIOZ ® is increased by approximately 2-fold compared with younger patients. Indication HETLIOZ ® is indicated for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24). Important Safety Information HETLIOZ ® may cause somnolence: After taking HETLIOZ ® , patients should limit their activity to preparing for going to bed, because HETLIOZ ® can potentially impair the performance of activities requiring complete mental alertness. The most common adverse reactions (incidence >5% and at least twice as high on HETLIOZ ® than on placebo) were headache, increased alanine aminotransferase, nightmares or unusual dreams, and upper respiratory or urinary tract infection. The risk of adverse reactions may be greater in elderly (>65 years) patients than younger patients because exposure to HETLIOZ ® is increased by approximately 2-fold compared with younger patients. Use of HETLIOZ ® should be avoided in combination with fluvoxamine or other strong CYP1A2 inhibitors, because of a potentially large increase in exposure of HETLIOZ ® , and a greater risk of adverse reactions. HETLIOZ ® should be avoided in combination with rifampin or other CYP3A4 inducers, because of a potentially large decrease in exposure of HETLIOZ ® , with reduced efficacy. There are no adequate and well-controlled studies of HETLIOZ ® in pregnant women. Based on animal data, HETLIOZ ® may cause fetal harm. HETLIOZ ® should be used during pregnancy only if the potential benefit justifies the potential risks. Caution should be exercised when HETLIOZ ® is administered to a nursing woman. HETLIOZ ® has not been studied in patients with severe hepatic impairment and is not recommended in these patients. Safety and effectiveness of HETLIOZ ® in pediatric patients have not been established. About Vanda Vanda is a global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. For more on Vanda Pharmaceuticals Inc. , please visit www.vandapharma.com . HETLIOZ ® is Vanda's registered trademark. Any other trademarks, registered marks and trade names and service marks appearing in this release are the property of their respective holders. Corporate Contact: Jim Kelly Executive Vice President and Chief Financial Officer Vanda Pharmaceuticals Inc. (202) 734-3428 [email protected] View original content: http://www.prnewswire.com/news-releases/fda-accepts-hetlioz-tasimelteon-supplemental-new-drug-application-for-review-in-the-treatment-of-jet-lag-disorder-300769351.html SOURCE Vanda Pharmaceuticals Inc.

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