ANDA 218217, held by Amneal. Lanreotide Acetate.
As of Nov 15, 2026, ANDA 218217 (Lanreotide Acetate), held by Amneal, was first approved by FDA on Sep 18, 2026, with 0 approved supplements and 0 published complete response letters.
Lanreotide injection is a somatostatin analog indicated for: the long-term treatment of acromegalic patients who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy. the treatment of adult patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival. the treatment of adults with carcinoid syndrome; when used, it reduces the frequency of short-acting somatostatin analog rescue therapy. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 18, 2026 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lanreotide AcetateEQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML) · solution;subcutaneous | Lanreotide Acetate | Rx |
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
