Tetrahydrobiopterin

Dr. Reddy's Laboratories Announces the Launch of a Generic Version of Sapropterin Dihydrochloride Powder for Oral Solution, 100 mg in the U.S. Market

Retrieved on: 
Wednesday, April 7, 2021

Dr. Reddys Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY along with its subsidiaries together referred to as Dr. Reddys) today announced the launch of Sapropterin Dihydrochloride Powder for Oral Solution, 100 mg, a therapeutic equivalent generic version of Kuvan (sapropterin dihydrochloride) Powder for Oral Solution, 100 mg, USP, approved by the U.S. Food and Drug Administration (USFDA).

Key Points: 
  • Dr. Reddys Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY along with its subsidiaries together referred to as Dr. Reddys) today announced the launch of Sapropterin Dihydrochloride Powder for Oral Solution, 100 mg, a therapeutic equivalent generic version of Kuvan (sapropterin dihydrochloride) Powder for Oral Solution, 100 mg, USP, approved by the U.S. Food and Drug Administration (USFDA).
  • We are pleased to launch this generic version of Sapropterin Dihydrochloride Powder for Oral Solution, illustrating our continued commitment to bring affordable generic medicines to market for patients, says Marc Kikuchi, Chief Executive Officer, North America Generics, Dr. Reddys Laboratories.
  • At the same time, this product demonstrates that we are actively expanding the breadth of our portfolio with a treatment for a rare disease.
  • Dr. Reddys Sapropterin Dihydrochloride Powder for Oral Solution, is available in 100 mg unit dose packets in a 30 count carton.

Dr. Reddy's Laboratories Announces the Launch of a Generic Version of Sapropterin Dihydrochloride Tablets for Oral Use in the U.S. Market

Retrieved on: 
Saturday, October 3, 2020

Dr. Reddys Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, along with its subsidiaries together referred to as Dr. Reddys) today announced the launch of a generic version of Sapropterin Dihydrochloride Tablets, for Oral Use.

Key Points: 
  • Dr. Reddys Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, along with its subsidiaries together referred to as Dr. Reddys) today announced the launch of a generic version of Sapropterin Dihydrochloride Tablets, for Oral Use.
  • We are pleased to launch this generic version of Sapropterin Dihydrochloride Tablets, for Oral Use, illustrating our continued commitment to bring affordable generic medicines to market for patients, says Marc Kikuchi, Chief Executive Officer, North America Generics, Dr. Reddys Laboratories.
  • At the same time, this product demonstrates that we are actively expanding the breadth of our portfolio with a treatment for a rare disease.
  • Dr. Reddys Sapropterin Dihydrochloride Tablets, 100 mg are available in bottle count sizes of 120.

BioMarin Announces Approval of VimizimĀ® (elosulfase alfa) in China for Treatment of Morquio A Syndrome

Retrieved on: 
Tuesday, June 4, 2019

Vimizim is the first treatment in China approved for this condition.

Key Points: 
  • Vimizim is the first treatment in China approved for this condition.
  • Morquio A syndrome is an ultra-rare, severely debilitating disease affecting an estimated 3,000 patients in the developed world.
  • "The approval of Vimizim in China underscores our commitment to providing this much-needed therapy to patients with Morquio A syndrome across the globe," said Hank Fuchs, M.D., President of Global Research and Development at BioMarin.
  • BioMarin Vimizim, and Kuvan are registered trademarks of BioMarin Pharmaceutical Inc.

BioMarin Announces First Quarter 2019 Financial Results

Retrieved on: 
Thursday, April 25, 2019

The complete Phase 3 GENEr8-1 study will include 130 participants, and is expected to be fully enrolled in the third quarter of 2019.

Key Points: 
  • The complete Phase 3 GENEr8-1 study will include 130 participants, and is expected to be fully enrolled in the third quarter of 2019.
  • Vosoritide for children with achondroplasia: The Company expects top line results from the ongoing global, Phase 3 study by year-end 2019.
  • BioMarin will host a conference call and webcast to discuss first quarter 2019 financial results today, Thursday, April 25, 2019 at 4:30 p.m.
  • BioMarin, Brineura, Firdapse, Kuvan,Naglazyme, Palynziq and Vimizim are registered trademarks of BioMarin Pharmaceutical Inc., or its affiliates.

BioMarin Announces 20 Poster Presentations at Society for the Study of Inborn Errors of Metabolism (SSIEM) Symposium 2018

Retrieved on: 
Wednesday, September 5, 2018

Intracerebroventricular cerliponase alfa in children with CLN2 disease: interim results from an ongoing multicenter, multinational extension study

Key Points: 
  • Intracerebroventricular cerliponase alfa in children with CLN2 disease: interim results from an ongoing multicenter, multinational extension study
    Efficacy & safety of sapropterin in PKU patients Bhattacharya K, Adams D, Belanger-Quintana A, Bushueva T, Cerone R, Chien N, Chiesa A, Coskun T, De la Heras Montero J, Feillet F, Katz R, Lagler F, Muntau A, Piazzon F, Rohr F, Spronsen F, Vargas P, Wilcox G
    An interim analysis of the KAMPER and PKUDOS registries: efficacy and safety of sapropterin before and during pregnancy

BioMarin Announces First Quarter 2018 Financial Results

Retrieved on: 
Wednesday, April 25, 2018

In the second quarter BioMarin intends to begin a Phase 1/2 Study with the 6e13 kg/vg dose and with approximately 10 patients who produce neutralizing antibodies against AAV5.

Key Points: 
  • In the second quarter BioMarin intends to begin a Phase 1/2 Study with the 6e13 kg/vg dose and with approximately 10 patients who produce neutralizing antibodies against AAV5.
  • On March 21, 2018, BioMarin announced that the International Society for Pharmaceutical Engineering selected the Company's gene therapy manufacturing facility as the 2018 Facility of the Year Category Winner for Project Execution.
  • BioMarin will host a conference call and webcast to discuss first quarter 2018 financial results today, Wednesday, April 25, 2018 at 4:30 p.m.
  • BioMarin, Brineura, Firdapse, Kuvan,Naglazyme and Vimizim are registered trademarks of BioMarin Pharmaceutical Inc., or its affiliates.