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https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/dr-reddys-recalls-six-lots-of-drug-in-us-due-to-subpotency/articleshow/109540120.cms

ECONOMICTIMES
23 Apr 2024

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/dr-reddys-issues-voluntary-nationwide-recall-sapropterin-dihydrochloride-powder-oral-solution-100-mg

FDA
23 Apr 2024

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

EMA
17 Nov 2022

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215420

FDA
18 Aug 2022

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215798

FDA
17 May 2022

https://www.ema.europa.eu/en/medicines/human/EPAR/sapropterin-dipharma

EMA
16 Mar 2022

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-march-02-2022-1646291076.pdf

FDA
02 Mar 2022

http://www.pharmatimes.com/news/kuvan_approved_for_pregnant_women_with_pku_in_uk_1375588

PHARMATIMES
23 Aug 2021

https://www.nice.org.uk/news/article/nice-draft-guidance-extends-recommendation-for-sapropterin-to-pregnant-women-and-people-aged-up-to-22-years-with-rare-inherited-metabolic-condition-phenylketonuria

NICE
20 Aug 2021

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207685

FDA
16 Jun 2021

https://www.nice.org.uk/news/article/nice-draft-guidance-recommends-sapropterin-for-children-with-rare-inherited-metabolic-condition-phenylketonuria#:~:text=NICE%20has%20today%20(25%20February,children%20aged%20up%20to%2018.&text=PKU%20is%20usually%20diagnosed%20in,chronic%20and%20life%2Dlong%20condition.

NICE
25 Feb 2021

https://www.businesswire.com/news/home/20201002005520/en

BUSINESSWIRE
03 Oct 2020

https://www.moneycontrol.com/news/business/dr-reddys-launches-generic-version-of-sapropterin-dihydrochloride-tablets-in-us-market-5917921.html

MONEYCONTROL
02 Oct 2020

https://www.prnewswire.com/news-releases/endo-begins-shipment-of-generic-kuvan-tablets-and-powder-for-oral-solution-sapropterin-dihydrochloride-301144510.html

PRNEWSWIRE
01 Oct 2020

https://www.prnewswire.com/news-releases/censa-pharmaceuticals-announces-cnsa-001-met-primary-and-secondary-endpoints-in-phase-2-trial-in-patients-with-pku-300968292.html

PR NEWSWIRE
03 Dec 2019

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210027

FDA
22 Aug 2019

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207200

FDA
14 May 2019

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207685

FDA
17 Dec 2018

http://www.pharmatimes.com/news/judge_rules_against_nhs_in_kuvan_funding_case_1200864

George Underwood PHARMA TIMES
09 Aug 2017

http://www.pmlive.com/pharma_news/judge_forces_nhs_england_rethink_on_kuvan_1200963

Phil Taylor PMLIVE
09 Aug 2017

http://www.prnewswire.com/news-releases/biomarin-announces-kuvan-sapropterin-dihydrochloride-patent-challenge-settlement-300439214.html

PR NEWSWIRE
13 Apr 2017

https://www.pharmacompass.com/pdf/news/Dipharma-announces-the-validation-of-disanit-nitisinone-marketing-authorization-application-in-Europe-1487846057.pdf

PRESS RELEASE
23 Feb 2017

http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207200

FDA
05 Dec 2016

http://www.reuters.com/article/us-biomarin-pharma-study-idUSKCN0WN0Z7

Natalie Grover REUTERS
22 Mar 2016

http://www.bizjournals.com/sanfrancisco/news/2017/02/06/biomarin-bmrn-dr-reddys-laboratories-rdy-kuvan-pku.html

BIZ JOURNALS
06 Feb 2016

http://www.fiercepharma.com/story/biomarin-pledges-588m-merck-kgaa-rare-disease-land-grab/2015-10-01

Tracy Staton FIERCE PHARMA
02 Oct 2015

http://www.financialexpress.com/article/industry/companies/dr-reddys-lab-biomarin-settle-kuvan-litigation/139321/

FE Bureau THE FINANCIAL EXPRESS
22 Sep 2015

http://investors.bmrn.com/releasedetail.cfm?ReleaseID=908731

Press Release BIOMARIN PHARM
27 Apr 2015
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