Application Nr Approved Date Route Status External Links
ANDA204024 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Fosamprenavir Calcium Tablets Are 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 Fosamprenavir Calcium Tabletsplus Ritonavir In Protease Inhibitor-Experienced Patients: • The Protease Inhibitor-Experienced Patient Trial Was Not Large Enough To Reach A Definitive Conclusion That Fosamprenavir Calcium Tabletsplus Ritonavir And Lopinavir Plus Ritonavir Are Clinically Equivalent [see Clinical Studies (14.2)] . • Once-Daily Administration Of Fosamprenavir Calcium Tabletsplus 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 Fosamprenavir Calcium Tabletsplus Ritonavir Is Not Recommended For Protease Inhibitor-Experienced Pediatric Patients Younger Than 6 Months [see Clinical Pharmacology (12.3)] . Fosamprenavir Calcium Tablet Are 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