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FDA - HIV and AIDS Activities - Antiretroviral Drugs Used in The Treatment of HIV Infection

This document lists 37 antiretroviral drugs approved by the FDA for treatment of HIV infection between 1987 and 2013. It provides the brand name, generic name, manufacturer, approval date and time taken for approval for each drug organized by drug class including: multi-class combination products, nucleoside reverse transcriptase inhibitors, nonnucleoside reverse transcriptase inhibitors, protease inhibitors, fusion inhibitors, CCR5 co-receptor antagonists, and HIV integrase strand transfer inhibitors. The fastest approval was 2.3 months and longest was 10 months. Generic versions of some drugs are also available.

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0% found this document useful (0 votes)
89 views5 pages

FDA - HIV and AIDS Activities - Antiretroviral Drugs Used in The Treatment of HIV Infection

This document lists 37 antiretroviral drugs approved by the FDA for treatment of HIV infection between 1987 and 2013. It provides the brand name, generic name, manufacturer, approval date and time taken for approval for each drug organized by drug class including: multi-class combination products, nucleoside reverse transcriptase inhibitors, nonnucleoside reverse transcriptase inhibitors, protease inhibitors, fusion inhibitors, CCR5 co-receptor antagonists, and HIV integrase strand transfer inhibitors. The fastest approval was 2.3 months and longest was 10 months. Generic versions of some drugs are also available.

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Made Yudana
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1/8/2014

HIV and AIDS Activities > Antiretroviral drugs used in the treatment of HIV infection

Home For Consumers Consumer Information by Audience For Patients and Patient Advocates HIV and AIDS Activities

For Consumers
Antiretroviral drugs used in the treatment of HIV infection
Drugs Used in the Treatment of HIV Infection
Click on drug brand name for additional information.
Multi-class Combination Products
Brand Name

Generic Name

Atripla1

efavirenz, emtricitabine
and tenofovir disoproxil
fumarate
emtricitabine, rilpivirine,
and tenofovir disoproxil
fumarate
elvitegravir, cobicistat,
emtricitabine, tenofovir
disoproxil fumarate

Complera2
Stribild3

Manufacturer Name*

Approval Date Time to


Approval
Bristol-Myers Squibb and Gilead 12-July-06
2.5 months
Sciences
Gilead Sciences

10-August-11

6 months

Gilead Sciences

27-August-12

6 months

Nucleoside Reverse Transcriptase Inhibitors (NRTIs)


Brand Name

Generic Name

Combivir4

lamivudine and zidovudine GlaxoSmithKline

Approval Date Time to


Approval
27-Sep-97
3.9 months

Emtriva5

Gilead Sciences
GlaxoSmithKline

02-Jul-03
17-Nov-95

10 months

Epivir6

emtricitabine, FTC
lamivudine, 3TC

Epzicom7

abacavir and lamivudine

GlaxoSmithKline

02-Aug-04

10 months

Hivid8

19-Jun-92

7.6 months

19-Mar-87

3.5 months

14-Nov-00

10.9 months

02-Aug-04

5 months

31-Oct-00

9 months

9-Oct-91

6 months

26-Oct-01

5.9 months

Zerit 15

zalcitabine,
Hoffmann-La Roche
dideoxycytidine, ddC (no
longer marketed)
zidovudine,
GlaxoSmithKline
azidothymidine, AZT, ZDV
abacavir, zidovudine, and GlaxoSmithKline
lamivudine
tenofovir disoproxil
Gilead Sciences, Inc.
fumarate and
emtricitabine
enteric coated didanosine, Bristol Myers-Squibb
ddI EC
didanosine,
Bristol Myers-Squibb
dideoxyinosine, ddI
tenofovir disoproxil
Gilead
fumarate, TDF
stavudine, d4T
Bristol Myers-Squibb

24-Jun-94

5.9 months

Ziagen16

abacavir sulfate, ABC

17-Dec-98

5.8 months

Retrovir9
Trizivir10
Truvada11
Videx EC12
Videx13
Viread14

Manufacturer Name*

GlaxoSmithKline

4.4 months

Nonnucleoside Reverse Transcriptase Inhibitors (NNRTIs)


Brand Name

Generic Name

Manufacturer Name*

rilpivirine

Tibotec Therapeutics

http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/HIVandAIDSActivities/ucm118915.htm

Approval Date Time to


Approval
20-May-11
10 months
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HIV and AIDS Activities > Antiretroviral drugs used in the treatment of HIV infection

Edurant 17
Intelence18

etravirine

Tibotec Therapeutics

18-Jan-08

Rescriptor19

delavirdine, DLV

Pfizer

4-Apr-97

6 months
8.7 months

Sustiva20

efavirenz, EFV

Bristol Myers-Squibb

17-Sep-98

3.2 months

Viramune21

nevirapine, NVP

Boehringer Ingelheim

21-Jun-96

3.9 months

Viramune XR22 nevirapine, NVP

Boehringer Ingelheim

25-Mar-11

9.9 months

(Im m e diate
R e le ase )
(Ex te nde d
R e le ase )

Protease Inhibitors (PIs)


Brand Name

Generic Name

Manufacturer Name*

Agenerase23

GlaxoSmithKline

Aptivus24

amprenavir, APV (no


longer marketed)
tipranavir, TPV

Approval Date Time to


Approval
15-Apr-99
6 months

Boehringer Ingelheim

22-Jun-05

6 months

Crixivan25

indinavir, IDV,

Merck

13-Mar-96

1.4 months

Fortovase26

saquinavir (no longer


Hoffmann-La Roche
marketed)
saquinavir mesylate, SQV Hoffmann-La Roche

7-Nov-97

5.9 months

6-Dec-95

3.2 months

Abbott Laboratories

15-Sep-00

3.5 months

GlaxoSmithKline

20-Oct-03

10 months

Norvir30

lopinavir and ritonavir,


LPV/RTV
Fosamprenavir Calcium,
FOS-APV
ritonavir, RTV

Abbott Laboratories

1-Mar-96

2.3 months

Prezista31

darunavir

Tibotec, Inc.

23-Jun-06

6 months

Reyataz32

atazanavir sulfate, ATV

20-Jun-03

6 months

Viracept 33

nelfinavir mesylate, NFV

Bristol-Myers Squibb
Agouron Pharmaceuticals

14-Mar-97

2.6 months

Approval Date Time to


Approval
13-Mar-03
6 months

Invirase27
Kaletra28
Lexiva29

Fusion Inhibitors
Brand Name

Generic Name

Manufacturer Name

Fuzeon34

enfuvirtide, T-20

Hoffmann-La Roche & Trimeris

Entry Inhibitors - CCR5 co-receptor antagonist


Brand Name

Generic Name

Manufacturer Name

Selzentry35

maraviroc

Pfizer

Approval Date Time to


Approval
06-August-07 8 months

HIV integrase strand transfer inhibitors


Brand Name

Generic Name

Manufacturer Name

Isentress36

raltegravir

Merck & Co., Inc.

Approval Date Time to


Approval
12--Oct-07
6 months

dolutegravir

GlaxoSmithKline

13-August-13

Tivicay37

38

6 months

*manufacturer/sponsor at time of approval


Generic drugs used in the Treatment of HIV Infection39
Approved and Tentatively Approved Antiretrovirals in Association with the President's Emergency Plan
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Page Last Updated: 05/16/2014
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1. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?
fuseaction=Search.SearchAction&SearchTerm=Atripla&SearchType=BasicSearch
2. http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202123s000lbl.pdf
3. http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203100s000lbl.pdf
4. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?
fuseaction=Search.SearchAction&SearchTerm=Combivir&SearchType=BasicSearch
5. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?
fuseaction=Search.SearchAction&SearchTerm=Emtriva&SearchType=BasicSearch
6. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?
fuseaction=Search.SearchAction&SearchTerm=Epivir&SearchType=BasicSearch
7. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?
fuseaction=Search.SearchAction&SearchTerm=Epzicom&SearchType=BasicSearch
8. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?
fuseaction=Search.SearchAction&SearchTerm=Hivid&SearchType=BasicSearch
9. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?
fuseaction=Search.SearchAction&SearchTerm=Retrovir&SearchType=BasicSearch
10. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?
fuseaction=Search.SearchAction&SearchTerm=Trizivir&SearchType=BasicSearch
11. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?
fuseaction=Search.SearchAction&SearchTerm=Truvada&SearchType=BasicSearch
12. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?
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13. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?
fuseaction=Search.SearchAction&SearchTerm=Videx&SearchType=BasicSearch
14. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?
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15. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?
fuseaction=Search.SearchAction&SearchTerm=Zerit&SearchType=BasicSearch
16. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?
fuseaction=Search.SearchAction&SearchTerm=Ziagen&SearchType=BasicSearch
17. http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202022s000lbl.pdf
18. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?
fuseaction=Search.SearchAction&SearchTerm=Intelence&SearchType=BasicSearch
19. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?
fuseaction=Search.SearchAction&SearchTerm=Rescriptor&SearchType=BasicSearch
20. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?
fuseaction=Search.SearchAction&SearchTerm=Sustiva&SearchType=BasicSearch
21. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?
fuseaction=Search.SearchAction&SearchTerm=Viramune&SearchType=BasicSearch
22. http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201152s000lbl.pdf
23. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?
fuseaction=Search.SearchAction&SearchTerm=Agenerase&SearchType=BasicSearch
24. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?
fuseaction=Search.SearchAction&SearchTerm=Aptivus&SearchType=BasicSearch
25. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?
fuseaction=Search.SearchAction&SearchTerm=Crixivan&SearchType=BasicSearch
26. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?
fuseaction=Search.SearchAction&SearchTerm=Fortovase&SearchType=BasicSearch
27. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?
fuseaction=Search.SearchAction&SearchTerm=Invirase&SearchType=BasicSearch
28. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?
fuseaction=Search.SearchAction&SearchTerm=Kaletra&SearchType=BasicSearch
29. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?
fuseaction=Search.SearchAction&SearchTerm=Lexiva&SearchType=BasicSearch
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fuseaction=Search.SearchAction&SearchTerm=Norvir&SearchType=BasicSearch
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fuseaction=Search.SearchAction&SearchTerm=Prezista&SearchType=BasicSearch
32. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?
fuseaction=Search.SearchAction&SearchTerm=Reyataz&SearchType=BasicSearch
33. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?
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34. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?
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35. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?
fuseaction=Search.SearchAction&SearchTerm=Selzentry&SearchType=BasicSearch
36. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?
fuseaction=Search.SearchAction&SearchTerm=Isentress&SearchType=BasicSearch
37. http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204790s001lbl.pdf
38. http://www.fda.gov/AboutFDA/AboutThisWebsite/WebsitePolicies/Disclaimers/default.htm
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39. /ForConsumers/ByAudience/ForPatientAdvocates/HIVandAIDSActivities/ucm118944.htm
40. /InternationalPrograms/FDABeyondOurBordersForeignOffices/AsiaandAfrica/ucm119231.htm

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