Sold as Glyset. Every FDA application for this active ingredient: 1 branded and 1 generic.
As of Nov 14, 2026, FDA lists 2 applications for Miglitol (sold as Glyset), first approved Dec 18, 1996, with 1 new use approved and 0 published complete response letters.
| Product | Part | Spending, 2025 | Change | Beneficiaries |
|---|---|---|---|---|
| Miglitol | Part D | $463K | -7% | 359 |
| Dec 18, 1996 | GlysetNDA 20682 · New molecular entity | Pfizer | 7 | Discontinued |
| Feb 24, 2015 | MiglitolANDA 203965 | Orient Pharma | 0 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
Pfizer