Treats advanced ovarian cancer. NDA 219920, held by Avyxa Holdings. Gemcitabine Hydrochloride.
As of Nov 13, 2026, NDA 219920 (Avgemsi), held by Avyxa Holdings, was first approved by FDA on Jun 27, 2025, with 1 approved supplement and 0 published complete response letters.
AVGEMSI is a nucleoside metabolic inhibitor indicated: in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. in combination with cisplatin, for the treatment of non-small cell lung cancer. as a single agent for the treatment of pancreatic cancer. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 27, 2025 | Original applicationNew formulation or manufacturer · Standard review | Approved | |
| Jun 27, 2025 | Supplement 1New formulation or manufacturer · Priority review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| AvgemsiEQ 200MG BASE/5.26ML (EQ 38MG BASE/ML) · solution;intravenous | Gemcitabine Hydrochloride | DiscontinuedReference drug |
| AvgemsiEQ 1GM BASE/26.3ML (EQ 38MG BASE/ML) · solution;intravenous | Gemcitabine Hydrochloride | RxReference drug |
| AvgemsiEQ 2GM BASE/52.6ML (EQ 38MG BASE/ML) · solution;intravenous | Gemcitabine Hydrochloride | 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
