FDA Approval for ARIKAYCE KIT issued to INSMED INC
$INSM
Biotechnology: Pharmaceutical Preparations
Health Care
New Drug Application (NDA): 207356
Company: INSMED INC
Company: INSMED INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ARIKAYCE KIT | AMIKACIN SULFATE | EQ 590MG BASE/8.4ML | SUSPENSION, LIPOSOMAL;INHALATION | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 09/28/2018 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207356s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207356Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/207356Orig1s000TOC.html |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/25/2026 | SUPPL-25 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/05/2025 | SUPPL-19 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/207356s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/207356Orig1s019ltr.pdf | |
| 06/01/2023 | SUPPL-13 | Labeling-Container/Carton Labels, Labeling-Medication Guide |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/207356Orig1s013ltr.pdf |
| 02/10/2023 | SUPPL-12 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/207356s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/207356Orig1s012ltr.pdf | |
| 03/13/2020 | SUPPL-4 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207356s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/207356Orig1s004ltr.pdf | |
| 10/19/2020 | SUPPL-3 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207356Orig1s003Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/207356Orig1s003ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/05/2025 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/207356s019lbl.pdf | |
| 02/10/2023 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/207356s012lbl.pdf | |
| 02/10/2023 | SUPPL-12 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/207356s012lbl.pdf | |
| 10/19/2020 | SUPPL-3 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207356Orig1s003Lbl.pdf | |
| 03/13/2020 | SUPPL-4 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207356s004lbl.pdf | |
| 03/13/2020 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207356s004lbl.pdf | |
| 09/28/2018 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207356s000lbl.pdf |