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Vemlidy FDA Approval History

FDA Approved: Yes (First approved November 10, 2016)
Brand name: Vemlidy
Generic name: tenofovir alafenamide
Dosage form: Tablets
Company: Gilead Sciences, Inc.
Treatment for: Hepatitis B

Last updated by Judith Stewart, BPharm on April 2, 2024.

Vemlidy (tenofovir alafenamide) is a hepatitis B virus (HBV) nucleoside analog reverse transcriptase inhibitor indicated for the treatment of chronic hepatitis B virus infection in adults and pediatric patients 6 years of age and older and weighing at least 25 kg with compensated liver disease.

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Development timeline for Vemlidy

DateArticle
Mar 28, 2024Approval FDA Expands Indication for Gilead's Vemlidy (tenofovir alafenamide) to Treat Chronic HBV Infection in Pediatric Patients as Young as Six
Nov  2, 2022Approval U.S. Food and Drug Administration Approves Vemlidy (tenofovir alafenamide) for Treatment of Chronic Hepatitis B Virus Infection in Pediatric Patients
Nov 10, 2016Approval FDA Approves Gilead’s Vemlidy (tenofovir alafenamide) for the Treatment of Chronic Hepatitis B Virus Infection
Jan 12, 2016Gilead Submits New Drug Application to U.S. FDA for Tenofovir Alafenamide (TAF) for the Treatment of Chronic Hepatitis B

See also

Vemlidy (tenofovir alafenamide) Consumer information

Further information

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