Post-Marketing Commitments and Requirements

Post-Marketing Commitments & Requirements

Established in 2006 by the merger of two 100-year-old Japanese pharmaceutical companies, Daiichi Sankyo, Inc. inherited a rich legacy of innovation and scientific expertise across therapeutic categories. Today, we're just as dedicated to improving quality of life for the patients who need our medicines as our founders were a century ago.
 
By continuing research on our products after FDA approval, we can continue to innovate and improve the quality of life for our patients. Studies, testing and other activities that Daiichi Sankyo, Inc. conducts in agreement with the FDA are referred to as post marketing commitments (PMCs) and post-marketing requirements (PMRs.) 
 
In March 2015, we began providing updates on the status of our PMCs and PMRs via this Web site. Click to view the Daiichi Sankyo, Inc. 2016 PMC & PMR Report. This report will be updated quarterly.  This report does not contain technical chemistry, manufacturing and control (CMC) commitments, nor does it contain commitments for medicines for which a Daiichi Sankyo group company is not the license holder.  For information about Effient, please visit the Eli Lilly and Company website. Information about Daiichi Sankyo, Inc.'s PMCs and PMRs is believed to be correct at the time that the information is posted. 
 
More information about the PMC and PMR processes can be found on the FDA website. The status of our PMCs and PMRs as shown on the FDA website may be different from information in our report, due to differences in the timing of updates between the two reports. Here are the explanations of terms found in our PMC and PMR report:
 
Column Heading Explanation

Product Name [TRADE NAME (generic name)]

Trade name used in the U.S. market (active ingredient[s] in the drug)

Due Date

The date by when Daiichi Sankyo, Inc. has agreed to a final submission to FDA relating to the post-marketing development activity

Activity Status (Delayed, Fulfilled, Ongoing, Pending, Released, Submitted, Terminated)

The status of the requirement at the last quarterly update (see definitions below)

Description of the Commitment A description of the development activity identified as a PMC or PMR

 

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As the U.S. subsidiary of a global pharmaceutical innovator, Daiichi Sankyo, Inc. draws on a rich heritage of innovation, integrity and accountability.

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