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Enforcement Report - Week of May 15, 2024
15 May 2024 //
FDA
Health Canada Issues Recall of Dr. Reddy`s Sapropterin
03 May 2024 //
HEALTH CANADA
Health Canada Issues Recall of Dr. Reddy`s Lab Canada`s Sapropterin
03 May 2024 //
HEALTH CANADA
Dr Reddy`s recalls six lots of drug in US due to subpotency
23 Apr 2024 //
ECONOMICTIMES
Dipharma`s Sapropterin Receives Approval in the Europe
17 Nov 2022 //
EMA
Annora`s Generic Sapropterin Dihydrochloride Receives Approval in the U.S.
18 Aug 2022 //
FDA
Enforcement Report - Week of March 02, 2022
02 Mar 2022 //
FDA
Kuvan approved for pregnant women with PKU in UK
23 Aug 2021 //
PHARMATIMES
NICE recommends sapropterin to pregnant women, people above 22 years PKU
20 Aug 2021 //
NICE
Dr Reddys`s Generic Sapropterin Dihydrochloride Receives Approval In US
16 Jun 2021 //
FDA
NICE draft guidance recommends sapropterin for children with rare inherited
25 Feb 2021 //
NICE
Dr. Reddy`s Announces the Launch of a Generic Version of Sapropterin
03 Oct 2020 //
BUSINESSWIRE
Dr Reddy`s launches generic version of Sapropterin Dihydrochloride tablets
02 Oct 2020 //
MONEYCONTROL
Endo Begins Shipment of Generic Kuvan® Tablets and Powder for Oral Solution
01 Oct 2020 //
PRNEWSWIRE
Censa Pharmaceuticals Announces CNSA-001 Met Primary and Secondary Endpoints
03 Dec 2019 //
PR NEWSWIRE
Par Pharm`s Generic Sapropterin Dihydrochloride Receives Approval in US
22 Aug 2019 //
FDA
Par Pharm`s Generic Sapropterin Dihydrochloride Receives Approval in US
14 May 2019 //
FDA
Dr Reddys Labs` Generic Sapropterin DiHCl Receives Tentative Approval in US
17 Dec 2018 //
FDA
Judge forces NHS England rethink on Kuvan
09 Aug 2017 //
PMLIVE
Judge rules against NHS in Kuvan funding case
09 Aug 2017 //
PHARMA TIMES
BioMarin Announces Kuvan sapropterin dihydrochloride Patent Challenge Settlement
13 Apr 2017 //
PR NEWSWIRE
Dipharma announces the validation of disanit® (nitisinone) marketing authorization application in Europe
23 Feb 2017 //
PRESS RELEASE
Dipharma & Alvogen announce launch of Diterin® 100mg tablets in South Korea
03 Feb 2017 //
PRESS RELEASE
Par`s Generic Sapropterin Dihydrochloride Receives Approval In US
05 Dec 2016 //
FDA
BioMarin drug fails to show inattention, mood benefit in study
22 Mar 2016 //
REUTERS
BioMarin sues to stop generic version of its $90K-a-year drug
06 Feb 2016 //
BIZ JOURNALS
BioMarin pledges up to $588M to Merck KGaA in rare-disease land grab
02 Oct 2015 //
FIERCE PHARMA
Dr Reddy’s Lab, BioMarin settle Kuvan litigation
22 Sep 2015 //
THE FINANCIAL EXPRESS
BioMarin submits NDA for drisapersen
27 Apr 2015 //
BIOMARIN PHARM
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