FDA Approved: FOCALIN — Supplemental Application (Sandoz Inc)

View source ↗

Summary

FDA approved a supplemental NDA for FOCALIN (dexmethylphenidate hydrochloride) from Sandoz Inc, indicating an approved change to the existing NDA.

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

Diseases / indications

• Attention Deficit Hyperactivity Disorder

Drugs mentioned

• FOCALIN (DEXMETHYLPHENIDATE HYDROCHLORIDE)

Snippet

SUPPL AP for FOCALIN (DEXMETHYLPHENIDATE HYDROCHLORIDE)