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FOTIVDA

Tivozanib · Capsule

Prescription NDA RLD

Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name

FOTIVDA

Generic name

Tivozanib

Dosage form

Capsule

Route

Oral

Marketing category

NDA · NDA

Labeler

AVEO Pharmaceuticals, Inc.

Product type

Human Prescription Drug

DEA schedule

Not scheduled

Active ingredients

NDC product codes

Packages

Data completeness

54% of corroborating sources present

Active ingredients

Source: NDC Directory

Active ingredients and strengths as listed in the NDC Directory.
Ingredient	Strength	RxCUI	Monograph
Tivozanib Hydrochloride	.89 mg/1	—	—
Tivozanib Hydrochloride	1.34 mg/1	—	—

Forms, strengths and routes

Source: NDC Directory

Dosage form

Capsule

Route of administration

Oral

Presentations

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory

Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class	Type	Browse
Kinase Inhibitor [EPC]	EPC	All 89 members
Tyrosine Kinase Inhibitors [MoA]	MoA	6 members — no class page

Regulatory status

Source: Drugs@FDA NDC Directory

Application number

212904

Application type

NDA · New Drug Application

Approval date

March 10, 2021

Sponsor

AVEO PHARMS

Products on application

Submissions recorded

Products approved under application 212904.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
212904-001	FOTIVDA	CAPSULE		TIVOZANIB HYDROCHLORIDE	Prescription	—	RLD
212904-002	FOTIVDA	CAPSULE		TIVOZANIB HYDROCHLORIDE	Prescription	—	RLD RS

Therapeutic equivalence

Source: Orange Book

TE code

—

Reference Listed Drug

Yes

Reference Standard

Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Patents and exclusivity

Source: Orange Book

Patent listings submitted under 21 U.S.C. 355(b)(1) and (c)(2).
Patent	Expires	Product	Substance	Use code	Submitted
7166722	November 16, 2028	001	Yes		April 6, 2021
7166722	November 16, 2028	002	Yes		April 6, 2021
11504365	November 5, 2039	001	No	U-3476	December 1, 2022
11504365	November 5, 2039	002	No	U-3476	December 1, 2022

Regulatory exclusivity periods.
Code	Expires	Product
NCE	March 10, 2026	001
NCE	March 10, 2026	002

Approval history

Source: Drugs@FDA

Most recent submissions on application 212904.
Type	No.	Action	Status	Date	Review
Supplement	3	Labeling	Approved	January 30, 2025	Standard
Supplement	2	Labeling	Approved	August 6, 2024	Standard
Original application	1	Type 1 - New Molecular Entity	Approved	March 10, 2021	Standard

Review documents

0 · Supplement · February 6, 2025
0 · Supplement · February 5, 2025
0 · Supplement · August 8, 2024
0 · Supplement · August 8, 2024
0 · Original application · April 27, 2021
0 · Original application · March 29, 2021
0 · Original application · March 11, 2021

Adverse event reports

Source: openFDA FAERS

1,578

FAERS reports mentioning this drug

as of 2026-09-25T03:42:24+00:00

A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: TIVOZANIB HYDROCHLORIDE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory

Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC	Product NDC	Labeler	Description	Marketing start
45629-089-02	45629-089	AVEO Pharmaceuticals, Inc.	1 BOTTLE, PLASTIC in 1 CARTON (45629-089-02) / 21 CAPSULE in 1 BOTTLE, PLASTIC	January 30, 2025
45629-134-02	45629-134	AVEO Pharmaceuticals, Inc.	1 BOTTLE, PLASTIC in 1 CARTON (45629-134-02) / 21 CAPSULE in 1 BOTTLE, PLASTIC	January 30, 2025
45629-089	45629-089	AVEO Pharmaceuticals, Inc.	—	March 10, 2021
45629-134	45629-134	AVEO Pharmaceuticals, Inc.	—	March 10, 2021

Sources for this page

Every dataset that contributed a fact to this page.
Dataset	Agency	Used for
NDC Directory	FDA	Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA	FDA	Application, sponsor, submissions, review documents, marketing status
Orange Book	FDA	Therapeutic equivalence codes, reference drug flags, patents, exclusivity
FAERS	FDA	Adverse event report counts

Generated September 25, 2026 · 11 sections on this page.