East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Sapropterin Dihydrochloride Tablets, 100 mg. Aurobindo Pharma’s Sapropterin Dihydrochloride Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), Kuvan Tablets manufactured by BioMarin Pharmaceutical Inc.

Sapropterin Dihydrochloride Tablets are 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).
• Used in conjunction with a Phe-restricted diet.