For octreotide or lanreotide. NDA 208232, held by Chiesi. Octreotide Acetate.
As of Nov 13, 2026, NDA 208232 (Mycapssa), held by Chiesi, was first approved by FDA on Jun 26, 2020, with 1 approved supplement and 1 published complete response letter.
MYCAPSSA is indicated for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 26, 2020 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Letter | Product | Now |
|---|---|---|
| Apr 15, 2016 | Mycapssa (octreotide) | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| MycapssaEQ 20MG BASE · capsule, delayed release;oral | Octreotide Acetate | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 11, 2024 | Supplement 6Labeling · Standard review | Approved | |
| Jun 26, 2020 | Original applicationNew formulation or manufacturer · Standard 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
