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Vijoice FDA Approval History

Last updated by Judith Stewart, BPharm on April 28, 2024.

FDA Approved: Yes (First approved April 5, 2022)
Brand name: Vijoice
Generic name: alpelisib
Dosage form: Tablets and Oral Granules
Company: Novartis Pharmaceuticals Corporation
Treatment for: PIK3CA-Related Overgrowth Spectrum

Vijoice (alpelisib) is a kinase inhibitor indicated for the treatment of adult and pediatric patients 2 years of age and older with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS) who require systemic therapy.

Development timeline for Vijoice

DateArticle
Apr  6, 2022Approval FDA Approves Vijoice (alpelisib) for the Treatment of PIK3CA-Related Overgrowth Spectrum (PROS)
Sep 17, 2021Novartis Announces Findings From a Real-World Study of Alpelisib Demonstrating Clinical Benefit in People with PIK3CA-Related Overgrowth Spectrum (PROS)

Further information

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