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  • INJECTABLE;INJECTION - EQ 0.05MG BASE/ML
  • INJECTABLE;INJECTION - EQ 0.1MG BASE/ML
  • INJECTABLE;INJECTION - EQ 0.2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • INJECTABLE;INJECTION - EQ 0.5MG BASE/ML
  • INJECTABLE;INJECTION - EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216807

FDA
13 Jun 2023

https://www.ema.europa.eu/en/documents/overview/mycapssa-epar-medicine-overview_en.pdf

EMA
22 Dec 2022

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-november-16-2022-42781.pdf

FDA
16 Nov 2022

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mylan-institutional-llc-viatris-company-issues-voluntary-recall-one-lot-octreotide-acetate-injection

FDA
27 Oct 2022

https://news.bloomberglaw.com/health-law-and-business/mylan-recalls-lot-of-octreotide-acetate-injection-500-mcg-ml?context=search&index=20

BLOOMBERGLAW
26 Oct 2022

https://www.globenewswire.com/news-release/2022/09/16/2517587/0/en/CHMP-adopts-positive-opinion-for-Mycapssa-for-the-treatment-of-Acromegaly.html

GLOBENEWSWIRE
16 Sep 2022

https://www.globenewswire.com/news-release/2022/09/07/2511277/0/en/Amryt-to-Present-Data-from-MPOWERED-Phase-3-Trial-of-Mycapssa-oral-octreotide-at-ENEA-2022.html

GLOBENEWSWIRE
07 Sep 2022

https://www.globenewswire.com/news-release/2022/07/14/2479558/0/en/Amryt-Receives-Orphan-Drug-Designation-from-the-FDA-for-Mycapssa-oral-octreotide-for-the-Treatment-of-Carcinoid-Syndrome.html

GLOBENEWSWIRE
14 Jul 2022

https://www.globenewswire.com/news-release/2022/06/08/2458549/0/en/Amryt-to-Present-Data-from-OPTIMAL-and-MPOWERED-Phase-3-Trials-Open-Label-Extension-of-Mycapssa-oral-octreotide-at-ENDO-2022.html

GLOBENEWSWIRE
08 Jun 2022

https://www.fiercepharma.com/manufacturing/tevas-halt-production-troubled-plant-seen-create-shortages-range-injectables

Joseph Keenan FIERCEPHARMA
24 May 2022

https://www.globenewswire.com/news-release/2022/04/13/2421761/0/en/Amryt-Announces-Positive-Long-Term-Safety-and-Efficacy-Data-for-Mycapssa-oral-octreotide-from-the-2nd-Year-of-OPTIMAL-Open-Label-Extension-Study-in-Acromegaly-Patients.html

GLOBENEWSWIRE
13 Apr 2022

https://www.globenewswire.com/news-release/2022/01/11/2364667/0/en/Amryt-Announces-Positive-Long-Term-Safety-and-Efficacy-Data-confirming-the-role-for-Mycapssa-oral-octreotide-in-the-management-of-Acromegaly-patients-who-have-responded-to-and-tole.html

GLOBENEWSWIRE
11 Jan 2022

https://trialsitenews.com/results-from-amyrt-pharmas-phase-3-mpowered-trial-of-mycapssa-oral-octreotide-for-acromegaly-published-in-the-lancet-diabetes-endocrinology/

TRIALSITENEWS
04 Jan 2022

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-august-25-2021-1629867988.pdf

FDA
25 Aug 2021

https://endpts.com/a-biotech-with-a-yen-for-pricey-rare-disease-drugs-and-bargain-basement-shopping-adopts-another-orphan-in-latest-ma-pact/

John Carroll ENDPTS
05 May 2021

https://ir.chiasma.com/news-releases/news-release-details/chiasma-announces-positive-topline-results-mpoweredtm-phase-3

PRESS RELEASE
18 Nov 2020

https://www.biospace.com/article/chiasma-s-octreotide-capsules-could-be-answer-to-acromegaly-patients-treatment-burdens/

Brandon May BIOSPACE
18 Sep 2020

https://www.globenewswire.com/news-release/2020/08/31/2086104/0/en/Chiasma-Announces-U-S-Commercial-Launch-and-Availability-of-MYCAPSSA-the-First-and-Only-Oral-Somatostatin-Analog-for-Patients-with-Acromegaly.html

GLOBENEWSWIRE
31 Aug 2020

https://www.globenewswire.com/news-release/2020/07/27/2068179/0/en/Chiasma-Announces-48-Week-Safety-and-Efficacy-Data-from-the-Open-Label-Extension-Study-of-its-CHIASMA-OPTIMAL-Phase-3-Trial-Evaluating-MYCAPSSA-in-Patients-with-Acromegaly.html

GLOBENEWSWIRE
27 Jul 2020

https://www.prnewswire.com/news-releases/camargo-client-chiasma-receives-fda-approval-for-first-and-only-oral-somatostatin-analog-for-long-term-maintenance-treatment-of-acromegaly-301087700.html

PRNEWSWIRE
02 Jul 2020

https://www.globenewswire.com/news-release/2020/06/26/2054210/0/en/Chiasma-Announces-FDA-Approval-of-MYCAPSSA-Octreotide-Capsules-the-First-and-Only-Oral-Somatostatin-Analog.html

GLOBENEWSWIRE
26 Jun 2020

https://www.fiercepharma.com/pharma/thanks-to-complex-manufacturing-novartis-expects-blockbuster-sandostatin-lar-to-steer-clear

Eric Sagonowsky FIERCE PHARMA
04 Feb 2020

https://www.in-pharmatechnologist.com/Article/2020/02/03/Novartis-expects-slow-erosion-by-Sandostatin-generics

Nick Taylor IN-PHARMATECHNOLOGIST
04 Feb 2020

https://cblpatras.gr/cbl-approved-by-ema-fda/

PRESS RELEASE
05 Dec 2019

https://www.fiercepharma.com/pharma/novartis-offloads-lagging-endocrine-drugs-pipeline-followup-to-recordati-for-390m?utm_source=internal&utm_medium=rss

Angus Liu FIERCE PHARMA
16 Jul 2019

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=204669

FDA
27 Dec 2018

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=203765

FDA
12 Sep 2018

https://www.fiercepharma.com/marketing/novartis-app-to-support-net-cancer-community-gets-apple-featured-boost

Beth Snyder Bulik FIERCE PHARMA
23 Jul 2018

http://www.pharmatimes.com/news/glide_raises_3.2m_for_solid_dose_injector_programme_1185653

Selina McKee PHARMATIMES
02 Feb 2017

http://www.fiercepharma.com/pharma/generics-set-to-undercut-blockbusters-from-merck-novartis-bms-2017

Eric Sagonowsky FIERCE PHARMA
18 Jan 2017

http://www.fiercepharma.com/marketing/fda-promo-police-slap-four-more-pharmas-year-end-enforcement-spree

Tracy Staton FIERCE PHARMA
30 Dec 2016

https://www.pharmacompass.com/pdf/news/us-fda-enforcement-report-1june2016-1464785216.pdf

FDA
31 May 2016

http://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/government-restores-customs-duty-exemption-on-three-drugs/articleshow/51028313.cms

ECONOMIC TIMES
17 Feb 2016

http://www.prnewswire.com/news-releases/glide-technologies-announces-successful-proof-of-concept-with-novel-exenatide-solid-dose-formulation-564345691.html

PR NEWS WIRE
05 Jan 2016

http://www.biospectrumindia.com/biospecindia/features/222801/acromegaly-treatment-oral-octreotide-capture-share-injectables-market-late-2015

BioSpectrum Bureau BIOSPECTRUM INDIA
18 Nov 2015

http://www.fiercebiotech.com/story/roche-out-door-chiasma-raising-56m-go-it-alone/2015-01-02

Damian Garde FIERCE BIOTECH
02 Jan 2015
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