FDA Approved: MIGLUSTAT — Original Application (Navinta LLC)

View source ↗

Summary

The FDA approved the Original Application (ANDA) for miglustat by Navinta LLC, granting a generic approval for the product.

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

Diseases / indications

• Niemann-pick Disease Type

Drugs mentioned

• Miglustat (miglustat)

Snippet

ORIG AP for MIGLUSTAT (MIGLUSTAT)