FDA Approved: PAROXETINE — Supplemental Application (Padagis US LLC)

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Summary

FDA approved a supplemental application for paroxetine submitted by Padagis US LLC, adding or updating labeling under the existing NDA.

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Diseases / indications

• Generalized Anxiety Disorder
• Major Depressive Disorder
• Obsessive-compulsive Disorder
• Panic Disorder
• Post-traumatic Stress Disorder
• Premenstrual Dysphoric Disorder
• Social Anxiety Disorder

Drugs mentioned

• Paroxetine (Paroxetine hydrochloride)

Snippet

SUPPL AP for PAROXETINE (PAROXETINE)