NDA 215395, held by Invagen Pharms. Lanreotide Acetate.
As of Nov 14, 2026, NDA 215395 (Lanreotide Acetate), held by Invagen Pharms, was first approved by FDA on Dec 17, 2021, 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.
| Sep 16, 2024 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | |
| Dec 17, 2021 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Lanreotide AcetateEQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML) · solution;subcutaneous | Lanreotide Acetate | DiscontinuedReference drug |
| Lanreotide AcetateEQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML) · solution;subcutaneous | Lanreotide Acetate | DiscontinuedReference drug |
| Lanreotide AcetateEQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML) · solution;subcutaneous | Lanreotide Acetate | DiscontinuedReference drug |
| Sep 16, 2024 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | |
| Jul 11, 2024 | Supplement 8Labeling · Standard review | Approved | |
| Dec 17, 2021 | 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
