Dr. Reddy’s Laboratories has launched Sapropterin Dihydrochloride Powder for Oral Solution, 100mg, a generic of BioMarin’s Kuvan (sapropterin dihydrochloride) Powder for Oral Solution, 100 mg, approved by the US Food and Drug Administration (USFDA) for the treatment of phenylketonuria.

Sapropterin dihydrochloride is indicated for the treatment of variant types of phenylketonuria (hyperphenylalaninaemia) associated with deficiency of tetrahydrobiopterin. It is an activator of phenylalanine hydroxylase.

Marc Kikuchi – CEO, North America Generics, Dr. Reddy’s Laboratories said: “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.”

Dr. Reddy’s Sapropterin Dihydrochloride Powder for Oral Solution has been launched in 100 mg unit dose packets. The company said that 30 packets are packed in the carton.

Last October, the Indian pharma company launched a generic version of phenylalanine hydroxylase activator Sapropterin Dihydrochloride Tablets, for oral use, in the US market.

  BioMarin, Dr. Reddy’s Laboratories, Kuvan, Marc Kikuchi, Phenylketonuria, USA