These days, everybody’s attention is focused is focused on COVID-19. However, that does not mean that the issues that the FDA was struggling with prior to the pandemic have disappeared. In fact, some rather major news regarding nitrosamine impurities was announced by the FDA yesterday (and it wasn’t an April Fools’ Day stunt!).
Yesterday, the FDA requested manufacturers’ market withdrawal of ranitidine (commonly known by the brand name Zantac), both prescription and OTC strengths. The FDA’s internal laboratories had found that N-nitrosodimethylamine (NDMA) levels in samples that were stored at room temperature (and at elevated temperatures) had increased above the acceptable daily intake of 96 nanograms per day in some samples. The FDA goes on to advise manufacturers that “any product in storage and not yet distributed would have to be evaluated following FDA guidance to show it would be safe throughout its shelf-life before the manufacturer can put it back on the market.” The FDA is not withdrawing approvals of any NDAs or ANDAs for ranitidine at this time. For any applications that have been submitted to the FDA already, it states that the “FDA will contact ANDA applicants as needed regarding pending submissions that are affected by this market withdrawal. If a company can show, through scientific data, that their ranitidine product is stable and the NDMA levels do not increase over time to unsafe levels, FDA may consider allowing that ranitidine product on the U.S. market.” This action also applies to compounded ranitidine and ranitidine that is used for veterinary applications.
A few months ago, we had published a paper in Contract Pharma on this issue. If you have a need to have a risk assessment for nitrosamine formation in your products, please contact Lachman at LCS@LachmanConsultants.com.
At a time when we are all at risk for ulcers due to worrying about COVID-19, we hope these products are returned to market shortly!