US FDA’s 30-Day Extension For Nitrosamine Assessments Short Of Industry Recommendation
Revision to FDA's September 2020 guidance on assessing nitrosamine impurity risks associated with all chemically synthesized APIs and all approved drug products that contain those APIs doesn’t satisfy industry stakeholders.
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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.
FDA requests immediate removal of ranitidine OTC and Rx drugs after third-party testing finds contaminant NDMA increases during storage, especially at higher temperatures. CDER Director Janet Woodcock asks firms to reformulate products to be stable as the ingredient remains approved.
Worldwide consumer health sales in January-March period were down 3.3% to $3.5bn with results off 7.4% to $1.6bn in the US and up 0.5% to $1.9bn internationally. However, excluding “COVID-19 comparison” in the year-ago period, the consumer health segment grew low-single-digits.