FDA — authorised 22 January 1981
- Application: ANDA062311
- Marketing authorisation holder: APOTHECON
- Local brand name: AMIKIN
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Amikacin Injection in United States
FDA authorised Amikacin Injection on 22 January 1981 · 10 US adverse-event reports
Marketing authorisations
FDA
- Application: ANDA062562
- Marketing authorisation holder: APOTHECON
- Local brand name: AMIKIN
- Indication: INJECTABLE — INJECTION
- 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: 22 April 2025 – 22 April 2026
- Total reports: 10
Most-reported reactions
- Acute Tonsillitis — 1 report (10%)
- Condition Aggravated — 1 report (10%)
- Constipation — 1 report (10%)
- Cough — 1 report (10%)
- Dental Caries — 1 report (10%)
- Dermatitis Allergic — 1 report (10%)
- Diarrhoea — 1 report (10%)
- Disease Recurrence — 1 report (10%)
- Dizziness — 1 report (10%)
- Drug Interaction — 1 report (10%)
Amikacin Injection in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Infectious Disease approved in United States
Frequently asked questions
Is Amikacin Injection approved in United States?
Yes. FDA authorised it on 22 January 1981; FDA has authorised it.
Who is the marketing authorisation holder for Amikacin Injection in United States?
APOTHECON holds the US marketing authorisation.