ANDA 217193, held by Invagen Pharms. Lanreotide Acetate.
As of Nov 15, 2026, ANDA 217193 (Lanreotide Acetate), held by Invagen Pharms, was first approved by FDA on May 21, 2024, with 2 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 |
|---|---|---|---|
| May 21, 2024 | Original application | Approved |
| Lanreotide AcetateEQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML) · solution;subcutaneous | Lanreotide Acetate | Discontinued |
| Lanreotide AcetateEQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML) · solution;subcutaneous | Lanreotide Acetate | Discontinued |
| Lanreotide AcetateEQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML) · solution;subcutaneous | Lanreotide Acetate | Discontinued |
| Oct 26, 2026 | Supplement 3Labeling · Standard review | Approved | None posted |
| Oct 26, 2026 | Supplement 2Labeling · Standard review | Approved | None posted |
| May 21, 2024 | Original application | 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
