Treats severe diarrhea and flushing episodes associated with metastatic carcinoid tumors. NDA 21008, held by Novartis. Octreotide Acetate.
As of Nov 13, 2026, NDA 21008 (Sandostatin Lar), held by Novartis, was first approved by FDA on Nov 25, 1998, with 28 approved supplements and 0 published complete response letters.
SANDOSTATIN LAR DEPOT 10 mg, 20 mg, and 30 mg is indicated in patients in whom initial treatment with Sandostatin Injection has been shown to be effective and tolerated. SANDOSTATIN LAR DEPOT is a somatostatin analogue indicated for: Treatment in patients who have responded to and tolerated Sandostatin Injection subcutaneous injection for: Acromegaly Severe diarrhea/flushing episodes associated with metastatic carcinoid tumors Profuse watery diarrhea associated with Vasoactive Intestinal Peptide (VIP) secreting tumors 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 3, 2008 | Supplement 21Efficacy (new indication or use) | Approved | |
| May 10, 2006 | Supplement 18Efficacy (new indication or use) · Priority review | Approved | |
| Nov 25, 1998 | Original applicationNew dosage form · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Sandostatin LarEQ 10MG BASE/VIAL · injectable;injection | Octreotide Acetate | RxReference drug |
| Sandostatin LarEQ 20MG BASE/VIAL · injectable;injection | Octreotide Acetate | RxReference drug |
| Sandostatin LarEQ 30MG BASE/VIAL · injectable;injection | Octreotide Acetate | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 11, 2024 | Supplement 49Labeling · Standard review | Approved | |
| Jan 5, 2024 | Supplement 47Labeling · Standard review | Approved | |
| Feb 9, 2023 | Supplement 46Manufacturing | Approved | |
| Mar 30, 2021 | Supplement 41Labeling · Standard review | Approved | |
| Apr 11, 2019 | Supplement 43Labeling | Approved | |
| Dec 21, 2018 | Supplement 36Labeling · Standard review | Approved | |
| Jul 22, 2016 | Supplement 35Manufacturing · Priority review | Approved | |
| May 20, 2016 | Supplement 34Manufacturing · Priority review | Approved | None posted |
| May 18, 2015 | Supplement 33Manufacturing · Priority review | Approved | None posted |
| Aug 21, 2014 | Supplement 32Manufacturing · Priority review | Approved | None posted |
| Jul 17, 2014 | Supplement 30Manufacturing · Priority review | Approved | |
| May 19, 2014 | Supplement 28Labeling · Standard review | Approved | |
| Jan 30, 2014 | Supplement 29Manufacturing · Priority review | Approved | None posted |
| Nov 30, 2012 | Supplement 27Manufacturing · Priority review | Approved | None posted |
| Sep 30, 2011 | Supplement 25Labeling · Standard review | Approved | |
| Jan 25, 2010 | Supplement 23Labeling · Standard review | Approved | |
| Mar 3, 2008 | Supplement 21Efficacy (new indication or use) | Approved | |
| May 10, 2006 | Supplement 18Efficacy (new indication or use) · Priority review | Approved | |
| May 10, 2006 | Supplement 19Labeling · Standard review | Approved | |
| Oct 14, 2004 | Supplement 15Labeling · Standard review | Approved | |
| Apr 19, 2004 | Supplement 6Labeling · Standard review | Approved | None posted |
| Apr 19, 2004 | Supplement 10Manufacturing · Priority review | Approved | |
| Dec 18, 2003 | Supplement 7Manufacturing · Priority review | Approved | |
| May 13, 2002 | Supplement 5Manufacturing · Priority review | Approved | None posted |
| Jan 3, 2002 | Supplement 4Manufacturing · Priority review | Approved | None posted |
| Jul 2, 2001 | Supplement 3Labeling · Standard review | Approved | None posted |
| Jul 13, 1999 | Supplement 2Manufacturing · Priority review | Approved | None posted |
| May 17, 1999 | Supplement 1Labeling · Standard review | Approved | None posted |
| Nov 25, 1998 | Original applicationNew dosage form · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
