US FDA Suggests Adding Antioxidants To Drug Formulations To Mitigate Nitrosamine Risks
Agency recommends “mitigation strategies” also including designing formulations that incorporate excipients such as sodium carbonate which modify the micro-environment to neutral or basic pH.
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Industry requests for deadline extensions, short-duration adjustments and other accommodations go nowhere as FDA expresses concerns about nitrosamines’ mutagenic potency.
Along with its Q1 results including a 7.3% drop in consumer health sales to €1.11bn ($1.35bn), Sanofi announces 10-mg famotidine tablets branded Zantac 360° will be available in the US in June.
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.