Occurrence of Selected Biological Generic Drug Products

Basic Details
Date Posted
Thursday, October 10, 2013
Status
Complete
Medical Product
adalimumab
darbepoetin alfa in albumin solution
darbepoetin alfa in polysorbate
epoetin alfa
filgrastim
infliximab
interferon beta-1A
interferon beta-1A/albumin
interferon beta-1B
pegfilgrastim
rituximab
somatropin
trastuzumab
Description

Summary table assessment of 13 selected biological generic drug products, including epoetin alfa, darbepoetin alfa in albumin solution, darbepoetin alfa in polysorbate, interferon beta-1A, interferon beta-1A/albumin, interferon beta-1B, pegfilgrastim, somatropin, rituximab, infliximab, adalimumab, trastuzumab, and filgrastim in the Mini-Sentinel Distributed Database. Results were generated using the Mini-Sentinel Distributed Query Tool and the Dispensing Summary Table.Summary tables are precompiled stratified counts. Queries were executed in July 2012. This report includes data from 16 Data Partners.

If you are using a web page screen reader and are unable to access this document, please contact the Mini-Sentinel Operations Center for assistance by clicking on the Submit Comments link above or sending an email requesting assistance to info@mini-sentinel.org.

The information contained on this website is provided as part of FDA's commitment to place knowledge acquired from the Mini-Sentinel pilot in the public domain as soon as possible. Please read the disclaimer.

Additional Details
FDA Center
CBER
Time Period
2010
Study Type
Summary Table
Assessment Type
Exploratory Analyses
Data Sources
Mini-Sentinel Distributed Database (MSDD)