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New dosing regimen for Lexiva approved

Food and Drug Administration - October 15, 2007
Richard Klein & Kimberly Struble

On October 12, 2007, the Food and Drug Administration (FDA) approved a supplemental new drug application for Lexiva (fosamprenavir calcium; FPV) Oral Tablets, adding a new indication for once-daily dosing of 1400 mg of Lexiva with 100 mg ritonavir for the treatment of HIV infection in therapy-naïve adults. The approval was based on a bioavailability study demonstrating that this dosing regimen produced drug levels bracketed within those of the already approved 1400 mg once daily plus ritonavir 200 mg once daily regimen, and the Lexiva1400 mg twice daily dosing regimen.

Lexiva is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection, and is distributed by GlaxoSmithKline, Research Triangle Park, NC.

A copy of the revised label, in a new, and easier to use format, is attached.

LexivaRevisedLabel.pdf

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration


071015
FD071003

SOURCE: Food and Drug Administration (FDA).

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