FDA Approved: FLUOXETINE — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)

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Summary

FDA approved a supplemental application for fluoxetine hydrochloride by PAI Holdings to modify the product labeling.

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Diseases / indications

• Bulimia Nervosa
• Major Depressive Disorder
• Obsessive-compulsive Disorder
• Panic Disorder
• Premenstrual Dysphoric Disorder

Drugs mentioned

• Fluoxetine (Fluoxetine)

Snippet

SUPPL AP for FLUOXETINE (FLUOXETINE HYDROCHLORIDE)