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https://endpts.com/fda-denies-hearing-to-vanda-on-jet-lag-indication-for-sleep-disorder-drug/

ENDPTS
06 Mar 2024

https://endpts.com/vanda-takes-issue-with-fdas-relay-of-deficiencies-for-new-hetlioz-indication/

ENDPTS
05 Feb 2024

https://www.prnewswire.com/news-releases/vanda-pharmaceuticals-responds-to-ruling-in-hetlioz-anda-appeal-301821307.html

PR NEWSWIRE
10 May 2023

https://www.prnewswire.com/news-releases/vanda-prevails-in-jet-lag-litigation-against-the-fda-301783748.html#:~:text=On%20March%2027%2C%202023%20a,%2C%20Hetlioz%C2%AE%20(tasimelteon).

PR NEWSWIRE
29 Mar 2023

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211654

FDA
12 Jan 2023

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211607

FDA
20 Dec 2022

https://www.fiercepharma.com/pharma/court-swats-way-vandas-infringement-claim-clearing-way-teva-apotex-generics

Kevin Dunleavy FIERCEPHARMA
15 Dec 2022

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211601

FDA
12 Dec 2022

https://endpts.com/cder-strikes-back-against-vanda-discloses-rationale-behind-2019-snda-rejection/

Paul Schloesser ENDPTS
10 Oct 2022

https://www.prnewswire.com/news-releases/vanda-pharmaceuticals-announces-notice-of-opportunity-for-an-fda-hearing-on-the-snda-for-hetlioz-in-jet-lag-disorder-301619811.html

PRNEWSWIRE
07 Sep 2022

https://endpts.com/vanda-takes-fda-to-court-again-this-time-seeking-more-info-on-a-rejection-letter/

Z. Brennan ENDPTS
12 Apr 2022

https://endpts.com/vanda-takes-fda-to-court-again-this-time-seeking-more-info-on-a-rejection-letter/

Zachary Brennan ENDPTS
11 Apr 2022

https://www.prnewswire.com/news-releases/vanda-pharmaceuticals-settles-hetlioz-patent-litigation-with-msn-301461230.html

PRNEWSWIRE
14 Jan 2022

https://www.prnewswire.com/news-releases/fda-approves-hetlioz-tasimelteon-for-the-treatment-of-nighttime-sleep-disturbances-in-smith-magenis-syndrome-301183162.html

PRNEWSWIRE
01 Dec 2020

https://www.prnewswire.com/news-releases/fda-accepts-and-grants-priority-review-of-vandas-applications-for-hetlioz-tasimelteon-in-the-treatment-of-smith-magenis-syndrome-301104479.html

PRNEWSWIRE
03 Aug 2020

https://www.prnewswire.com/news-releases/vanda-pharmaceuticals-announces-agreement-with-fda-on-resubmission-of-the-application-for-hetlioz-for-the-treatment-of-patients-with-smith-magenis-syndrome-301058197.html

PRNEWSWIRE
13 May 2020

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211607

FDA
06 Feb 2020

https://pharmaphorum.com/news/vanda-pharmaceuticals-perplexed-by-fda-rejection-of-jet-lag-drug/

Richard Staines PHARMAPHORUM
22 Aug 2019

https://www.prnewswire.com/news-releases/vanda-announces-listing-of-a-new-hetlioz-patent-in-the-fda-orange-book-300716505.html

PR NEWSWIRE
20 Sep 2018

https://www.pharmacompass.com/pdf/news/hetlioztasimelteon-vanda-pharmaceuticals-v-msn-pharmaceuticals-inc-1526283229.pdf

PATENT LITIGATION
07 May 2018

https://www.pharmacompass.com/pdf/news/hetlioztasimelteon-vanda-pharmaceuticals-v-apotex-1526283328.pdf

PATENT LITIGATION
07 May 2018

https://www.pharmacompass.com/pdf/news/fda-confirms-paragraph-iv-patent-challenge-of-hetlioz-tasimelteon-new-capsules-1522389927.pdf

FDA
29 Mar 2018

https://www.biospace.com/article/vanda-pharmaceuticals-hetlioz-shows-promise-for-treating-jet-lag/

Mark Terry BIOSPACE
05 Mar 2018

http://www.prnewswire.com/news-releases/hetlioz-is-now-available-for-the-treatment-of-non-24-hour-sleep-wake-disorder-in-germany-300306709.html

PR NEWSWIRE
01 Aug 2016

http://www.wsj.com/articles/new-drug-ads-tout-serious-conditions-costly-treatments-1455661823

Peter Loftus WSJ
17 Feb 2016

http://www.pharmabiz.com/NewsDetails.aspx?aid=89294&sid=2

PHARMABIZ
07 Jul 2015

http://blogs.wsj.com/pharmalot/2015/06/11/fda-mistakenly-widened-the-market-for-a-rare-sleep-disorder-drug-petition/

Ed Silverman PHARMALOT
12 Jun 2015

http://www.pmlive.com/pharma_news/bms_opdivo_backed_as_melanoma_therapy_in_eu_721486

Phil Taylor PM LIVE
27 Apr 2015

http://www.pharmatimes.com/Article/15-04-26/Eleven_medicines_leap_closer_to_approval_in_Europe.aspx

Selina Mckee PHARMATIMES
26 Apr 2015

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2015/04/news_detail_002315.jsp&mid=WC0b01ac058004d5c1

EMA
24 Apr 2015

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2015/04/news_detail_002310.jsp&mid=WC0b01ac058004d5c1

EMA
24 Apr 2015
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