FDA — authorised 27 July 2011
- Application: ANDA090912
- Marketing authorisation holder: STRIDES PHARMA
- Local brand name: ACARBOSE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 alpha-glucosidase inhibitors in United States
FDA authorised alpha-glucosidase inhibitors on 27 July 2011 · 25 US adverse-event reports
Marketing authorisations
FDA — authorised 7 February 2012
- Application: ANDA202271
- Marketing authorisation holder: AVET LIFESCIENCES
- Local brand name: ACARBOSE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 February 2015
- Application: ANDA203965
- Marketing authorisation holder: ORIENT PHARMA
- Local brand name: MIGLITOL
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 25
Most-reported reactions
- Cerebral Infarction — 7 reports (28%)
- Acute Myocardial Infarction — 2 reports (8%)
- Altered State Of Consciousness — 2 reports (8%)
- Angina Pectoris — 2 reports (8%)
- Cough — 2 reports (8%)
- Diabetic Nephropathy — 2 reports (8%)
- Fall — 2 reports (8%)
- Interstitial Lung Disease — 2 reports (8%)
- Malaise — 2 reports (8%)
- Palpitations — 2 reports (8%)
alpha-glucosidase inhibitors in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is alpha-glucosidase inhibitors approved in United States?
Yes. FDA authorised it on 27 July 2011; FDA authorised it on 7 February 2012; FDA authorised it on 24 February 2015.
Who is the marketing authorisation holder for alpha-glucosidase inhibitors in United States?
STRIDES PHARMA holds the US marketing authorisation.