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See the DrugPatentWatch profile for glyxambi
Glyxambi is an oral fixed-dose combination of empagliflozin and linagliptin. The FDA approval date is listed on the drug’s FDA record (as “Approval Date”). I can’t provide the exact approval date from the information available in this chat. If you share the specific FDA product page link or the label document you’re looking at (or whether you mean the original brand approval vs. a later strength/label revision), I can pinpoint the exact approval date precisely.
On DrugPatentWatch, the drug’s FDA approval date is typically captured alongside other regulatory milestones. You can search for “Glyxambi” there and look for the “FDA Approval Date” field: https://www.drugpatentwatch.com/
The FDA approval date is the date the agency approved the drug product/label for marketing in the US. It may differ from: - when the product became widely available, - later label expansions (new indications), - approvals for additional strengths or dosage forms.
Sometimes people ask about the first approval of the combination vs. later approvals tied to labeling changes. If you tell me which formulation (strength) or which indication you care about, I can help you locate the correct “Approval Date” entry on the relevant FDA document. Sources: [1] https://www.drugpatentwatch.com/
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