Tenofovir: Difference between revisions

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See also [[Tenofovir (patient information)]].
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==History==
==Overview==
Viread brand of tenofovir was approved for Gilead Sciences by the [[Food and Drug Administration]] in the [[United States]] with a [http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/NewDrugApplicationNDA/ New Drug Application] (NDA) in 2001.<ref>{{FDA-Drug_Details|021356}}</ref>


A generic version with a AB [[Food and Drug  Administration/Catalogs/Therapeutic Equivalence Code|Therapeutic Equivalence Code]] was approved for Cipla Limited with a [http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/ Abbreviated New Drug Application] (ANDA) in 2009.<ref>{{FDA-Drug_Details|078800}}</ref> The generic ANDA was reviewed under the expedited review provisions of the President’s Emergency Plan for AIDS Relief (PEPFAR) with the agreement that the drug would not be marketed in the United States until the Viread patent protection expires in 2017.


==references==
==Category==
<references/>
 
 
==US Brand Names==
  Viread<sup>®</sup>
 
==FDA Package Insert==
 
'''  [[XXXXX description|Description]]'''
'''| [[XXXXX clinical pharmacology|Clinical Pharmacology]]'''
'''| [[XXXXX microbiology|Microbiology]]'''
'''| [[XXXXX indications and usage|Indications and Usage]]'''
'''| [[XXXXX contraindications|Contraindications]]'''
'''| [[XXXXX warnings and precautions|Warnings and Precautions]]'''
'''| [[XXXXX adverse reactions|Adverse Reactions]]'''
'''| [[XXXXX drug interactions|Drug Interactions]]'''
'''| [[XXXXX overdosage|Overdosage]]'''
'''| [[XXXXX clinical studies|Clinical Studies]]'''
'''| [[XXXXX dosage and administration|Dosage and Administration]]'''
'''| [[XXXXX how supplied|How Supplied]]'''
'''| [[XXXXX labels and packages|Labels and Packages]]'''
 
==Mechanism of Action==
 
 
 
==References==
 
{{Reflist|2}}
 
[[Category:Antibiotics]]
[[Category:Wikinfect]]

Revision as of 15:06, 2 January 2014