Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 021106
Company: PHARMACIA
Company: PHARMACIA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SOMAVERT | PEGVISOMANT | 10MG/VIAL | INJECTABLE;SUBCUTANEOUS | Prescription | None | No | No |
SOMAVERT | PEGVISOMANT | 15MG/VIAL | INJECTABLE;SUBCUTANEOUS | Prescription | None | No | No |
SOMAVERT | PEGVISOMANT | 20MG/VIAL | INJECTABLE;SUBCUTANEOUS | Prescription | None | No | No |
SOMAVERT | PEGVISOMANT | 25MG/VIAL | INJECTABLE;SUBCUTANEOUS | Prescription | None | No | No |
SOMAVERT | PEGVISOMANT | 30MG/VIAL | INJECTABLE;SUBCUTANEOUS | Prescription | None | No | 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 |
---|---|---|---|---|---|---|---|
03/25/2003 | ORIG-1 | Approval | N/A; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21106_somavert_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21106ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021106_somavert.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/27/2023 | SUPPL-74 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021106s074lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021106Orig1s074ltr.pdf | |
08/20/2021 | SUPPL-68 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021106s067s068lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021106Orig1s067,s068ltr.pdf | |
08/20/2021 | SUPPL-67 | Supplement |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021106s067s068lbl.pdf | |
09/19/2019 | SUPPL-64 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021106s064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021106Orig1s064ltr.pdf | |
08/16/2019 | SUPPL-55 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021106s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021106Orig1s055ltr.pdf | |
04/22/2016 | SUPPL-50 | Supplement |
Label is not available on this site. |
||
01/11/2016 | SUPPL-48 | Supplement |
Label is not available on this site. |
||
02/22/2016 | SUPPL-46 | Supplement |
Label is not available on this site. |
||
09/24/2019 | SUPPL-45 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021106Orig1s045ltr.pdf |
07/31/2014 | SUPPL-44 | Supplement |
Label is not available on this site. |
||
10/11/2013 | SUPPL-43 | Supplement |
Label is not available on this site. |
||
09/26/2013 | SUPPL-42 | Supplement |
Label is not available on this site. |
||
03/01/2013 | SUPPL-39 | Supplement |
Label is not available on this site. |
||
12/10/2013 | SUPPL-36 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021106s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021106Orig1s036ltr.pdf | |
07/03/2012 | SUPPL-31 | Supplement |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021106s031lbl.pdf | |
07/20/2010 | SUPPL-28 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021106s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021106s028ltr.pdf | |
10/03/2008 | SUPPL-16 | Supplement |
Label is not available on this site. |
||
08/18/2008 | SUPPL-15 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021106s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021106s015ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
07/27/2023 | SUPPL-74 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021106s074lbl.pdf | |
08/20/2021 | SUPPL-68 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021106s067s068lbl.pdf | |
08/20/2021 | SUPPL-68 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021106s067s068lbl.pdf | |
08/20/2021 | SUPPL-68 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021106s067s068lbl.pdf | |
08/20/2021 | SUPPL-67 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021106s067s068lbl.pdf | |
08/20/2021 | SUPPL-67 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021106s067s068lbl.pdf | |
08/20/2021 | SUPPL-67 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021106s067s068lbl.pdf | |
09/19/2019 | SUPPL-64 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021106s064lbl.pdf | |
08/16/2019 | SUPPL-55 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021106s055lbl.pdf | |
12/10/2013 | SUPPL-36 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021106s036lbl.pdf | |
07/03/2012 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021106s031lbl.pdf | |
07/20/2010 | SUPPL-28 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021106s028lbl.pdf | |
08/18/2008 | SUPPL-15 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021106s015lbl.pdf | |
03/25/2003 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21106_somavert_lbl.pdf |