New Draft Guidance on Bioequivalence Recommendations for Iron Sucrose Injection
The US Food and Drug Administration (FDA) released new draft guidance for industry on 27 March entitled Bioequivalence (BE) Recommendations for Iron Sucrose. The guidance instructs industry how to design BE studies to support abbreviated new drug applications (ANDAs) for iron sucrose injection products.
To date, there are no approved ANDAs for iron sucrose injection, which was first approved in November 2000 by FDA for the treatment of iron deficiency anemia in people with kidney disease.
FDA is calling for comments on the draft guidance to be submitted within 60 days of the posting's date of publication in the Federal Register.
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