PTC Therapeutics, Inc. has announced a significant step forward in its mission to combat phenylketonuria (PKU) by receiving FDA acceptance for the New Drug Application (NDA) of Sepiapterin. The acceptance of this NDA, supported by positive clinical trial results, brings much-needed hope to patients managing this rare metabolic disorder. The FDA’s action sets a critical […]
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 […]
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- […]