FDA Approved: VIVELLE-DOT — Supplemental Application (Sandoz Inc)

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Summary

FDA approved a supplemental application for Vivelle-Dot (estradiol) submitted by Sandoz Inc, updating the product’s labeling via a supplemental approval.

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Diseases / indications

• Postmenopausal Osteoporosis
• Vasomotor Symptoms Due to Menopause

Drugs mentioned

• VIVELLE-DOT (ESTRADIOL)

Snippet

SUPPL AP for VIVELLE-DOT (ESTRADIOL)