Indian pharma company Dr. Reddy’s Laboratories has launched a generic version of phenylalanine hydroxylase activator Sapropterin Dihydrochloride Tablets, for oral use, in the US market.
Sapropterin Dihydrochloride Tablets are indicated in the US for reducing blood phenylalanine (Phe) levels in adult and pediatric patients, aged one month and older with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU).
The phenylalanine hydroxylase activator is to be used in conjunction with a Phe-restricted diet.
Marc Kikuchi – CEO of Dr. Reddy’s Laboratories North America Generics said: “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.
“At the same time, this product demonstrates that we are actively expanding the breadth of our portfolio with a treatment for a rare disease. We are pleased to provide financial support to patients by offering a co-pay card program for eligible patients, details will be available on our website.”
Dr. Reddy’s Sapropterin Dihydrochloride Tablets, 100 mg have been available in bottle count sizes of 120.