Frindovyx

NDA 210852, held by Avyxa Holdings. Cyclophosphamide.

As of Nov 13, 2026, NDA 210852 (Frindovyx), held by Avyxa Holdings, was first approved by FDA on Jun 7, 2023, with 2 approved supplements and 6 published complete response letters.

First approved: Jun 7, 2023
Review: Standard
Supplements approved: 2
Complete response letters: 6

What It's For

From the FDA-approved label (Indications and Usage)

Malignant Diseases FRINDOVYX is indicated for the treatment of adult and pediatric patients with: malignant lymphomas (Stages III and IV of the Ann Arbor staging system), Hodgkin's disease, lymphocytic lymphoma (nodular or diffuse), mixed-cell type lymphoma, histiocytic lymphoma Burkitt's lymphoma multiple myeloma leukemias: chronic lymphocytic leukemia, chronic granulocytic leukemia (it is usually ineffective in acute blastic crisis), acute myelogenous and monocytic leukemia, acute lymphoblastic (stem-cell) leukemia (cyclophosphamide given during remission is effective in prolonging its duration) mycosis fungoides (advanced disease) neuroblastoma (disseminated disease) adenocarcinoma of the…

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Jun 7, 2023	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Label Letter

Complete Response Letters

FDA's published letters for this application; each opens the letter

Letter	Product	Now
Apr 18, 2022	CyclophosphamideFacility Inspections	Approved
Nov 6, 2020	CyclophosphamideFacility Inspections	Approved
May 21, 2020	CyclophosphamideFacility Inspections	Approved
Nov 20, 2019	CyclophosphamideFacility Inspections	Approved
May 3, 2019	CyclophosphamideFacility Inspections	Approved
Jul 24, 2018	CyclophosphamideFacility Inspections	Approved

Products

3 strengths and forms

Product	Active ingredient	Marketing
Frindovyx500MG/ML (500MG/ML) · solution;intravenous	Cyclophosphamide	RxReference drug
Frindovyx1GM/2ML (500MG/ML) · solution;intravenous	Cyclophosphamide	RxReference drug
Frindovyx2GM/4ML (500MG/ML) · solution;intravenous	Cyclophosphamide	RxReference drug

All 3 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Aug 1, 2025	Supplement 6Labeling · Standard review	Approved	Letter Label
Jan 24, 2025	Supplement 5Labeling · Standard review	Approved	Letter Label
Jun 7, 2023	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Label Letter

Identifiers

Application: NDA 210852
Drugs@FDA: Overview at FDA
Company: Avyxa Holdings

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