FDA Approved: JAVYGTOR — Supplemental Application (Dr. Reddys Laboratories Inc)

View source ↗

Summary

The FDA approved a supplemental application for JAVYGTOR (sapropterin dihydrochloride) submitted by Dr. Reddys Laboratories Inc.

Upgrade for the full analysis, importance score, and drug timeline.

Diseases / indications

• Phenylketonuria
• Tetrahydrobiopterin Deficiency

Drugs mentioned

• JAVYGTOR (Sapropterin dihydrochloride)

Snippet

SUPPL AP for JAVYGTOR (SAPROPTERIN DIHYDROCHLORIDE)