Viread

Product manufactured by Remedyrepack Inc.

Application Nr Approved Date Route Status External Links
NDA021356 2012-01-18 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Viread Is A Nucleotide Analog Hiv-1 Reverse Transcriptase Inhibitor And An Hbv Reverse Transcriptase Inhibitor. Viread Is Indicated In Combination With Other Antiretroviral Agents For The Treatment Of Hiv-1 Infection In Adults And Pediatric Patients 2 Years Of Age And Older. ( 1) Viread Is Indicated For The Treatment Of Chronic Hepatitis B In Adults And Pediatric Patients 12 Years Of Age And Older. ( 1) 1.1 Hiv-1 Infection Viread Is Indicated In Combination With Other Antiretroviral Agents For The Treatment Of Hiv-1 Infection In Adults And Pediatric Patients 2 Years Of Age And Older. Viread ® Is Indicated In Combination With Other Antiretroviral Agents For The Treatment Of Hiv-1 Infection In Adults And Pediatric Patients 2 Years Of Age And Older. The Following Points Should Be Considered When Initiating Therapy With Viread For The Treatment Of Hiv-1 Infection:the Following Points Should Be Considered When Initiating Therapy With Viread For The Treatment Of Hiv-1 Infection: Viread Should Not Be Used In Combination With Atripla ®, Complera ®, Descovy ®, Genvoya ®, Odefsey ®, Stribild ®, Truvada ®, Or Vemlidy ® [see Warnings And Precautions (5.4)] . Viread Should Not Be Used In Combination With Atripla ®, Complera ®, Descovy ®, Genvoya ®, Odefsey ®, Stribild ®, Truvada ®, Or Vemlidy ® [see Warnings And Precautions (5.4)] . 1.2 Chronic Hepatitis B Viread Is Indicated For The Treatment Of Chronic Hepatitis B In Adults And Pediatric Patients 12 Years Of Age And Older . The Following Points Should Be Considered When Initiating Therapy With Viread For The Treatment Of Hbv Infection: The Indication In Adults Is Based On Safety And Efficacy Data From Treatment Of Subjects Who Were Nucleoside-Treatment-Naïve And Subjects Who Were Treatment-Experienced With Documented Resistance To Lamivudine. Subjects Were Adults With Hbeag-Positive And Hbeag-Negative Chronic Hepatitis B With Compensated Liver Disease [see Clinical Studies (14.2)]. Viread Was Evaluated In A Limited Number Of Subjects With Chronic Hepatitis B And Decompensated Liver Disease [see Adverse Reactions (6.1), Clinical Studies (14.2)] . The Numbers Of Subjects In Clinical Trials Who Had Adefovir Resistance-Associated Substitutions At Baseline Were Too Small To Reach Conclusions Of Efficacy [see Microbiology (12.4), Clinical Studies (14.2)].

All Formulated Excipients (4 Total)

Name Structure Kind Function Status
1. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
2. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
3. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
4. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Tenofovir Disoproxil Fumarate

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