FDA Approved: DRIZALMA SPRINKLE — Supplemental Application (SUN PHARMACEUTICAL INDUSTRIES, INC.)

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Summary

The FDA approved Sun Pharmaceutical's supplemental NDA for Drizalma Sprinkle (duloxetine), adding a sprinkle-form formulation and related labeling enhancements.

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Diseases / indications

• Diabetic Peripheral Neuropathic Pain
• Fibromyalgia
• Generalized Anxiety Disorder
• Major Depressive Disorder
• Musculoskeletal Pain

Drugs mentioned

• Drizalma Sprinkle (Duloxetine)
• Duloxetine (DULOXETINE)

Snippet

SUPPL AP for DRIZALMA SPRINKLE (DULOXETINE)