Perrigo Among Firms Requesting Delay In Conducting US Nitrosamine Risk Assessments
• By Joanne S. Eglovitch
Perrigo, Pfizer want FDA to postpone its March deadline for conducting nitrosamine risk assessments. Generics executive cites “serious compliance challenges” in conducting these assessments due to difficulty in finding the right lab equipment necessary to quantify nitrosamine daily intake limits.
After OTC and Rx drugs containing ranitidine and other ingredients were linked to nitrosamine, firms marketing drugs in the US have until 1 March to test for impurity risks from the potential carcinogenic associated with chemically synthesized APIs and all approved drugs that contain those APIs.
Some pharmaceutical firms are asking the US Food and Drug Association for more time to assess the presence of cancer-causing nitrosamines in new and approved products.
Their reasons are varied. For example, Perrigo Company PLC says internal testing sites have been affected by stay-at-home orders...
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