FDA — authorised 15 July 2019
- Application: ANDA210118
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: ICATIBANT ACETATE
- Indication: INJECTABLE — SUBCUTANEOUS
- Status: approved
🇺🇸 ICATIBANT ACETATE in United States
FDA authorised ICATIBANT ACETATE on 15 July 2019 · 1,273 US adverse-event reports
Marketing authorisations
FDA — authorised 9 March 2020
- Application: ANDA211021
- Marketing authorisation holder: JIANGSU HANSOH PHARM
- Local brand name: ICATIBANT ACETATE
- Indication: INJECTABLE — SUBCUTANEOUS
- Status: approved
FDA — authorised 18 June 2020
- Application: ANDA208317
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: ICATIBANT ACETATE
- Indication: INJECTABLE — SUBCUTANEOUS
- Status: approved
FDA — authorised 13 July 2020
- Application: ANDA212446
- Marketing authorisation holder: CIPLA
- Local brand name: ICATIBANT ACETATE
- Indication: INJECTABLE — SUBCUTANEOUS
- Status: approved
FDA — authorised 2 September 2020
- Application: ANDA211501
- Marketing authorisation holder: WILSHIRE PHARMS INC
- Local brand name: ICATIBANT ACETATE
- Indication: INJECTABLE — SUBCUTANEOUS
- Status: approved
FDA — authorised 16 December 2020
- Application: ANDA212081
- Marketing authorisation holder: NANG KUANG PHARM CO
- Local brand name: ICATIBANT ACETATE
- Indication: INJECTABLE — SUBCUTANEOUS
- Status: approved
FDA — authorised 21 May 2021
- Application: ANDA213222
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: ICATIBANT ACETATE
- Indication: INJECTABLE — SUBCUTANEOUS
- Status: approved
FDA — authorised 14 August 2023
- Application: ANDA213521
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: ICATIBANT ACETATE
- Indication: INJECTABLE — SUBCUTANEOUS
- Status: approved
FDA — authorised 14 June 2024
- Application: ANDA213773
- Marketing authorisation holder: ALEMBIC
- Local brand name: ICATIBANT ACETATE
- Indication: INJECTABLE — SUBCUTANEOUS
- 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: 1,273
Most-reported reactions
- Hereditary Angioedema — 421 reports (33.07%)
- Weight Decreased — 187 reports (14.69%)
- Weight Increased — 186 reports (14.61%)
- Product Dose Omission Issue — 87 reports (6.83%)
- Abdominal Distension — 85 reports (6.68%)
- Off Label Use — 64 reports (5.03%)
- Pharyngeal Swelling — 64 reports (5.03%)
- Drug Ineffective — 62 reports (4.87%)
- Product Use Issue — 59 reports (4.63%)
- Swelling Face — 58 reports (4.56%)
ICATIBANT ACETATE 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 ICATIBANT ACETATE approved in United States?
Yes. FDA authorised it on 15 July 2019; FDA authorised it on 9 March 2020; FDA authorised it on 18 June 2020.
Who is the marketing authorisation holder for ICATIBANT ACETATE in United States?
TEVA PHARMS USA holds the US marketing authorisation.