Dr. Reddy's Laboratories Ltd on Tuesday announced that it is voluntarily recalling six lots of Sapropterin Dihydrochloride Powder for Oral Solution 100 mg in the U.S. due to powder discoloration in some packets, leading to decreased potency
Dr. Reddy’s Issues Voluntary Nationwide Recall of Sapropterin Dihydrochloride Powder for Oral Solution 100 mg Due to Sub-Potency
Dipharma`s Sapropterin Receives Approval in the Europe
Annora's Generic Sapropterin Dihydrochloride Disodium Receives Approval in the U.S.
Dr. Reddy`s Generic Sapropterin dihydrochloride Receives Approval in the U.S.
Dipharma B.V.'s Generic Sapropterin Hydrochloride Receives Approval in Europe
Enforcement Report - Week of March 02, 2022
The National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending BioMarin's Kuvan (sapropterin) as an option for treating phenylketonuria (PKU) in pregnant women until they give birth, as well as for treating the condition in people until they turn 22.
Usually diagnosed in children, PKU is a rare, inherited, chronic and life-long metabolic condition. It is caused by the deficiency of an enzyme which breaks down phenylalanine, a compound which occurs naturally in protein-rich foods such as milk, eggs and meat. Phenylalanine in high concentrations is toxic to the central nervous system.
Dr Reddys`s Generic Sapropterin Dihydrochloride Receives Approval In US