FDA Must Reconsider Vanda’s Bid for Jet Lag Indication on HETLIOZ
A court victory forces the Food and Drug Administration to re-examine rejected application for expanded indication.
Tag: Vanda Pharmaceuticals
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FDA Flags Deficiencies in Vanda’s Insomnia sNDA
Vanda received notification from the FDA regarding deficiencies in its supplemental new drug application for Hetlioz in treating insomnia.
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Vanda to Resubmit FDA Application for HETLIOZ for Sleep Disturbance in Patients with Smith-Magenis Syndrome
Vanda Pharmaceuticals Inc has completed a Type A Meeting with the US Food and Drug Administration (FDA) on May 8, 2020, it has reached agreement with the FDA to resubmit its application for HETLIOZ (tasimelteon) for the treatment of Smith-Magenis Syndrome.
Read MoreVanda Pharmaceuticals President Gets Award for Work To Prevent Dog Testing
Mihael H. Polymeropoulos, MD, president and CEO of Vanda Pharmaceuticals, marketers of HETLIOZ (tasimelteon, indicated for non-24-hour sleep-wake disorder) is the inaugural recipient of “The Trailblazer Award.”The...
Read MoreFDA To Vanda: HETLIOZ Jet Lag Disorder Measures of “Unclear Clinical Significance”
Vanda Pharmaceuticals Inc received a complete response letter (CRL) from the US Food and Drug Administration (FDA) on Aug 16 as part of the FDA’s ongoing review of Vanda’s supplemental New Drug Application...
Read MoreVanda Receives FDA Deficiencies Notice for Hetlioz Supplemental New Drug Application for Jet Lag Disorder; Vanda Plans to Work with FDA to Resolve
Vanda Pharmaceuticals Inc received a notification from the US Food and Drug Administration (FDA) on July 19 stating that as part of its ongoing review of Vanda’s supplemental New Drug Application (sNDA) for HETLIOZ...
Read MoreFDA Accepts HETLIOZ Supplemental New Drug Application for Review in Treatment of Jet Lag
The US 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...
Read MoreHETLIOZ Improves Sleep Quality in Patients with Smith-Magenis Syndrome, Finds Clinical Study
HETLIOZ (tasimelteon) improved sleep quality and increased sleep duration in patients with Smith-Magenis Syndrome (SMS) in a placebo-controlled clinical study, reports marketer Vanda Pharmaceuticals Inc. “We are extremely...
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The Sleep Scientists Embarking on Jet Lag Studies
Scientists and entrepreneurs are joining forces to meet a growing demand for solutions to jet lag.
Read MoreNew HETLIOZ Patent Listed in the FDA Orange Book
Vanda Pharmaceuticals Inc announced that a HETLIOZ patent, number 10,071,977 (‘977 patent), is now listed in the U.S. Food and Drug Administration publication Approved Drug Products With Therapeutic Equivalence...
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New Vanda Pharmaceuticals’ Abstracts Suggest Circadian Components of Major Depressive Disorder
The maker of Hetlioz (tasimelteon) presented 4 abstracts at World Sleep 2017. By Dillon Stickle...
Read MoreHETLIOZ Now Available for Treatment of Non-24-Hour Sleep-Wake Disorder in Germany
Vanda Pharmaceuticals Inc announced that HETLIOZ (tasimelteon) is now available for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) in Germany. “The launch of HETLIOZ in Germany reflects our continued focus to...
Read MoreHetlioz Gets European Commission Approval for Treatment of Non-24 in Totally Blind
The European Commission (EC) approved Vanda Pharmaceuticals Inc’s Hetlioz (tasimelteon) for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) in totally blind adults in the European Union (EU). “The European...
Read MoreVanda Receives Innovation Award from the National Organization for Rare Disorders
Vanda Pharmaceuticals Inc received the 2015 Industry Innovation Award from the National Organization of Rare Disorders (NORD) in recognition of Vanda’s work in developing Hetlioz (tasimelteon) for the treatment of...
Read MoreIn 1Q2015, Hetlioz Net Product Sales Up 24% Over Prior Quarter
Vanda Pharmaceuticals Inc today announced financial and operational results for the first quarter ended March 31, 2015. “The first quarter of 2015 was a record quarter for product sales driven by Hetlioz and Fanapt. As we...
Read MoreIn Europe, Hetlioz Receives Positive CHMP Opinion
European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of Vanda Pharmaceuticals’ Hetlioz (tasimelteon) for the treatment of...
Read MoreNational Organization for Rare Disorders to Honor Hetlioz
On May 19, the National Organization for Rare Disorders (NORD) will honor the patients, leaders, and innovators who are moving the rare disease community forward at its annual Portraits of Courage Gala in Washington DC. NORD is...
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