Elvitegravir/Cobicistat/Emtricitabine/Tenofivir disoproxil/Alafenamide - Genvoya (Nov 2015)- Anti-viral

Drug Name:
Elvitegravir/Cobicistat/Emtricitabine/Tenofivir disoproxil/Alafenamide - Genvoya (Nov 2015)- Anti-viral

List Of Brands:

Indication Type Description:

Indication

Dosages/ Overdosage Etc

   

Indication:

Drug Name- Stribild
 
Active Ingredient -  Elvitegravir/Cobicstat/Emcitabine/Tenofovir disoproxil fumarate
 
Once a day combination pill to treat HIV-1 infection in adults who never been 
treated for HIV-infection
 
Indication-
Combination pill to treat HIV-1 infecton
 
Approved by FDA  on 27-8--2012  (Ref- FDA Approved List- 2012) 
 
 
NEW MOLECULAR ENTITY AND NEW THERAPEUTIC BIOLOGICAL
 
PRODUCTS APPROVED FOR 2015
 
Certain drugs are classified as New molecular Emtities- NME- for FDA review 
Many of these products contain active moieties that have not been approved
by FDA  previously, either as a single ingredient or as part of a combination
products; these products frequently provide important new therapies for the
patients.
 
Some drugs are characterized as NMEs for administrative purposes ,but 
nonetheless contain certain active moieties in products that have been 
previously approved by FDA. For example, CDER  classifies biological 
products submitted in an application under section 351(a) of the Public
Service Act as NME for purposes of FDA review, regardless of whether 
the agency previously  approved a related active moiety in  a different 
product. 
 
FDAs classification of a drug as an -NME- for review purposes is distinct
from FDAs determination of whether a drug is a - New Chemical Entity or - NCE-
within the meaning of the Federal Food,Drug, and  Cosmetic Act
 
 
No.34
 
Drug Name - Fixed dose combination tablet containing Elvitegravir
                      + Cobicisstat + Emtricitabine + Tenofovir Alafenamide
 
Active Ingredient-  Genvoya
 
Date of approval -  11/05/2015
 
FDA-approved use -  For use as a complete regimen for the treatment of 
                                     HIV-1 infection in adults and pediatric patients 
                                     12 years of age and older                                       
 
Approved by US FDA  on 11/05/2015-   (Ref- FDA approved List- 2015)