Lexiva

Product manufactured by Viiv Healthcare Company

Application Nr Approved Date Route Status External Links
NDA021548 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Lexiva Is Indicated In Combination With Other Antiretroviral Agents For The Treatment Of Human Immunodeficiency Virus (Hiv-1) Infection. The Following Points Should Be Considered When Initiating Therapy With Lexiva Plus Ritonavir In Protease Inhibitor-Experienced Patients: • The Protease Inhibitor-Experienced Patient Trial Was Not Large Enough To Reach A Definitive Conclusion That Lexiva Plus Ritonavir And Lopinavir Plus Ritonavir Are Clinically Equivalent [See Clinical Studies ( 14.2 )] . • Once-Daily Administration Of Lexiva Plus Ritonavir Is Not Recommended For Adult Protease Inhibitor-Experienced Patients Or Any Pediatric Patients [See Dosage And Administration ( 2.2 , 2.3 ), Clinical Studies ( 14.2 , 14.3 )] . • Dosing Of Lexiva Plus Ritonavir Is Not Recommended For Protease Inhibitor-Experienced Pediatric Patients Younger Than 6 Months [See Clinical Pharmacology ( 12.3 )]. Lexiva Is An Hiv Protease Inhibitor Indicated In Combination With Other Antiretroviral Agents For The Treatment Of Hiv-1 Infection. ( 1 )

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Fosamprenavir Calcium FOSAMPRENAVIR CALCIUM ZINC3941829

Comments