🇺🇸 Insulin Degludec and Insulin Aspart in United States

FDA authorised Insulin Degludec and Insulin Aspart on 30 August 2021 · 11 US adverse-event reports

Marketing authorisations

FDA — authorised 30 August 2021

  • Application: ANDA208336
  • Marketing authorisation holder: SUNSHINE
  • Local brand name: LINAGLIPTIN AND METFORMIN HYDROCHLORIDE
  • Indication: TABLET — ORAL
  • Status: approved

Read official source →

FDA — authorised 31 August 2021

  • Application: ANDA208335
  • Marketing authorisation holder: SUNSHINE
  • Local brand name: LINAGLIPTIN
  • Indication: TABLET — ORAL
  • Status: approved

Read official source →

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.

Most-reported reactions

  1. Blood Glucose Increased — 2 reports (18.18%)
  2. Abdominal Distension — 1 report (9.09%)
  3. Adrenal Insufficiency — 1 report (9.09%)
  4. Adrenocorticotropic Hormone Deficiency — 1 report (9.09%)
  5. Cachexia — 1 report (9.09%)
  6. Decreased Appetite — 1 report (9.09%)
  7. Haemolytic Anaemia — 1 report (9.09%)
  8. Hepatic Function Abnormal — 1 report (9.09%)
  9. Immune-Mediated Hypothyroidism — 1 report (9.09%)
  10. Lacunar Infarction — 1 report (9.09%)

Source database →

Insulin Degludec and Insulin Aspart 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 Insulin Degludec and Insulin Aspart approved in United States?

Yes. FDA authorised it on 30 August 2021; FDA authorised it on 31 August 2021; FDA has authorised it.

Who is the marketing authorisation holder for Insulin Degludec and Insulin Aspart in United States?

SUNSHINE holds the US marketing authorisation.