The Center for Drug Evaluation (CDE) has released the 61st batch of chemical generic reference preparations, adding 34 new specifications and updating information for 36 previously published ones.
Batch Details
The latest batch includes updates to existing specifications and introduces new ones. However, 27 specifications failed the review due to various issues, including uncertain originator status, lack of approval in major markets like the US, Europe, and Japan, and previous review failures.
Specific Case
Tranexamic acid and sodium chloride injection was ordered for a re-review. The decision was based on the drug’s earlier approval date in China compared to the US, significant discrepancies in indications between domestic and international markets, and insufficient evidence to prove its originator status.-Fineline Info & Tech
