EA Review #2, NDA 20-358                                                                                                                               Page 3

 

SUMMARY:

 

The information provided regarding manufacturing and disposal indicates that the process is adequately controlled to limit emissions into the environment.  The 5th year production estimate for bupropion hydrochloride is (whited out).  The company performed microbial inhibition testing and reported the available mammalian toxicity data.  The MIC’s for the tested microorganisms were ≥ 1000 ppm.  No additional ecotoxicity testing were performed. The compound is inherently photogradable which will efficiently remove the compound from the environment and therefore no additional toxicity testing was requesting by CDER.

 

 

 

 

 

 

 

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