Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 203858
Company: CHIESI
Company: CHIESI
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| JUXTAPID | LOMITAPIDE MESYLATE | EQ 5MG BASE | CAPSULE;ORAL | Prescription | None | Yes | No |
| JUXTAPID | LOMITAPIDE MESYLATE | EQ 10MG BASE | CAPSULE;ORAL | Prescription | None | Yes | No |
| JUXTAPID | LOMITAPIDE MESYLATE | EQ 20MG BASE | CAPSULE;ORAL | Prescription | None | Yes | No |
| JUXTAPID | LOMITAPIDE MESYLATE | EQ 30MG BASE | CAPSULE;ORAL | Prescription | None | Yes | No |
| JUXTAPID | LOMITAPIDE MESYLATE | EQ 40MG BASE | CAPSULE;ORAL | Discontinued | None | Yes | No |
| JUXTAPID | LOMITAPIDE MESYLATE | EQ 60MG BASE | CAPSULE;ORAL | Discontinued | None | Yes | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/21/2012 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203858s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203858Orig1s000ltr_replace.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/2038858_juxtapid_toc.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/16/2022 | SUPPL-24 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/203858Orig1s024ltr.pdf |
| 02/01/2022 | SUPPL-23 | REMS - MODIFIED - D-N-A |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/203858Orig1s023ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/203858Orig1s023.pdf |
| 05/27/2021 | SUPPL-22 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/203858Orig1s022ltr.pdf |
| 12/20/2019 | SUPPL-19 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203858s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/203858Orig1s019ltr.pdf | |
| 06/04/2018 | SUPPL-18 | REMS - PROPOSAL - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203858Orig1s018ltr.pdf |
| 08/02/2017 | SUPPL-17 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203858s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203858Orig1s017ltr.pdf | |
| 01/03/2017 | SUPPL-16 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203858Orig1s013,s016ltr.pdf |
| 05/23/2016 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203858s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203858Orig1s015ltr.pdf | |
| 07/11/2016 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/03/2017 | SUPPL-13 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203858Orig1s013,s016ltr.pdf |
| 03/08/2016 | SUPPL-12 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203858s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203858Orig1s012ltr.pdf | |
| 04/24/2015 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/23/2015 | SUPPL-10 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203858s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203858Orig1s010ltr.pdf | |
| 08/08/2014 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203858s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203858Orig1s009ltr.pdf | |
| 11/11/2014 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/18/2014 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203858s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203858Orig1s006ltr.pdf | |
| 04/23/2014 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/17/2013 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/10/2013 | SUPPL-2 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203858s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203858Orig1s002ltr.pdf | |
| 08/13/2013 | SUPPL-1 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203858Orig1s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/20/2019 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203858s019lbl.pdf | |
| 08/02/2017 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203858s017lbl.pdf | |
| 05/23/2016 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203858s015lbl.pdf | |
| 03/08/2016 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203858s012lbl.pdf | |
| 04/23/2015 | SUPPL-10 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203858s010lbl.pdf | |
| 08/08/2014 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203858s009lbl.pdf | |
| 02/18/2014 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203858s006lbl.pdf | |
| 04/10/2013 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203858s002lbl.pdf | |
| 12/21/2012 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203858s000lbl.pdf |