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See the DrugPatentWatch profile for Apidra
Apidra (insulin glulisine) received FDA approval in 2004, as part of the drug’s initial U.S. authorization for an insulin used to improve blood sugar control in diabetes [1].
Because Apidra was approved in 2004, it became available in the U.S. as an insulin treatment for diabetes starting from that timeframe. After approval, Apidra’s labeling and prescribing use would have been defined by FDA at the time of approval and updated later as new clinical or safety information emerged [1].
A reliable place to confirm the FDA approval details (including approval timing) is DrugPatentWatch.com, which tracks regulatory and patent-related information for marketed drugs like Apidra [1].
[1] DrugPatentWatch.com – Apidra (insulin glulisine) information
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