Treats m eta static c a rcinoid t u mo rs. NDA 213224, held by Sun Pharm. Octreotide Acetate.
As of Nov 14, 2026, NDA 213224 (Bynfezia Pen), held by Sun Pharm, was first approved by FDA on Sep 27, 2024, with 0 approved supplements and 0 published complete response letters.
BYNFEZIA PEN is a s o matostatin analogue indicated: Acromegaly: To reduce blood levels of growth hormone (GH) and insulin growth factor 1 (IGF-1; somatomedin C) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses. (1.1) Carcinoid Tumors: For the symptomatic treatment of patients with m eta static c a rcinoid t u mo rs where it suppresses or inhibits the severe diarrhea and flushing episodes associated with the disease. (1.2) Vasoactive Intestinal Peptide Tumors (VIPomas): For the treatment of profuse watery diarrhea associated with VIP-secreting tumors. (1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 27, 2024 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Bynfezia PenEQ 7MG BASE/2.8ML (EQ 2.5MG BASE/ML) · solution;subcutaneous | Octreotide Acetate | RxReference drug |
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
