Dr Reddy’s Laboratories 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 US Food and Drug Administration (USFDA).
Sapropterin dihydrochloride is a phenylalanine hydroxylase activator indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients one month of age and older with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU). Sapropterin dihydrochloride powder for oral solution is to be used in conjunction with a Phe-restricted diet.
“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. At the same time, this product demonstrates that we are actively expanding the breadth of our portfolio with a treatment for a rare disease,” Marc Kikuchi, Chief Executive Officer, North America Generics, Dr Reddy’s Laboratories.
Dr Reddy’s Sapropterin Dihydrochloride Powder for Oral Solution, is available in 100 mg unit dose packets in a 30 count carton.