FDA Approved: SAPROPTERIN DIHYDROCHLORIDE — Original Application (Hikma Pharmaceuticals USA Inc.)

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Summary

FDA approved Hikma Pharmaceuticals USA Inc.'s sapropterin dihydrochloride via an original application, adding a new approved product for management of phenylket…

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Diseases / indications

• Phenylketonuria
• Tetrahydrobiopterin Deficiency

Drugs mentioned

• Sapropterin dihydrochloride (Sapropterin dihydrochloride)

Snippet

ORIG AP for SAPROPTERIN DIHYDROCHLORIDE (SAPROPTERIN DIHYDROCHLORIDE)