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Tivicay FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 28, 2021.

FDA Approved: Yes (First approved August 12, 2013)
Brand name: Tivicay
Generic name: dolutegravir
Dosage form: Tablets
Company: ViiV Healthcare
Treatment for: HIV Infection

Tivicay (dolutegravir) is a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI) indicated for use in combination with other antiretroviral (ARV) agents for the treatment of HIV-1.

Development timeline for Tivicay

Jun 12, 2020Approval FDA Approves Tivicay PD (dolutegravir) Once-Daily Dispersible Tablet Formulation for Children with HIV
Aug 12, 2013Approval FDA Approves Tivicay (dolutegravir) to Treat HIV Infection
Dec 18, 2012ViiV Healthcare Announces Regulatory Submissions for Dolutegravir in the EU, US and Canada

Further information

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