TUDRIQEV Suspension for injection Ref.[116925] Active ingredients: Vusolimogene oderparepvec

Source: FDA, National Drug Code (US) Revision Year: 2026

Product description

TUDRIQEV (vusolimogene oderparepvec-wtpg) is a genetically modified herpes simplex virus, type 1 (HSV-1) oncolytic viral therapy that encodes a fusogenic glycoprotein derived from gibbon ape leukemia virus with the R sequence deleted (GALV-GP-R^–) and human granulocyte-macrophage colony-stimulating factor (GM-CSF). The genes encoding the HSV-1 neurovirulence factor ICP34.5 and the transporter associated with antigen presentation inhibitor ICP47 are deleted from TUDRIQEV.

TUDRIQEV is a sterile frozen, preservative free, suspension for intratumor injection provided in single-dose glass vials. Each vial contains an extractable volume of 1 mL of TUDRIQEV at a concentration of either 10⁶ PFU/mL or 10⁷ PFU/mL formulated in disodium hydrogen phosphate dihydrate (7 mg), sodium dihydrogen phosphate dihydrate (1.4 mg), sodium chloride (1.3 mg), myo-inositol (39 mg), d-sorbitol (19.5 mg), recombinant human serum albumin (5.1 mg) with water for injection.

After thawing, TUDRIQEV is a colorless, translucent to opaque suspension and may contain visible, white to off-white, or colorless particles or fibers that may appear globular or amorphous. These particulates are inherent to the formulation.

Dosage Forms and Strengths
TUDRIQEV is a colorless, translucent to opaque suspension provided as a 1 mL extractable volume in a single-dose vial in the following concentrations: Starting dose: 10⁶(1 million) PFU per mL suspension (white cap) Subsequent doses: 10⁷(10 million) PFU per mL suspension (blue cap)

How Supplied
TUDRIQEV is supplied as a sterile frozen liquid in a single-dose borosilicate glass vial with a bromobutyl stopper, aluminum seal, and a flip-off plastic cap. TUDRIQEV is a suspension that is not under pressure and is not aerosolized. Each vial contains an extractable volume of 1 mL for injection. The vial polypropylene cap is color coded: 10⁶ PFU per mL is white [NDC: 83616-106-01 (vial); NDC: 83616-106-11 (carton)] 10⁷ PFU per mL is blue [NDC: 83616-107-01 (vial); NDC: 83616-107-11 (carton)] Manufactured by: Replimune, Inc., 33 New York Ave Ste 100, Framingham, MA 01701 Marketed by: Replimune, Inc., 500 Unicorn Park Drive, Woburn, MA 01801

How Supplied

TUDRIQEV is supplied as a sterile frozen liquid in a single-dose borosilicate glass vial with a bromobutyl stopper, aluminum seal, and a flip-off plastic cap. TUDRIQEV is a suspension that is not under pressure and is not aerosolized.

Each vial contains an extractable volume of 1 mL for injection.

The vial polypropylene cap is color coded:

10⁶ PFU per mL is white [NDC: 83616-106-01 (vial); NDC: 83616-106-11 (carton)]
10⁷ PFU per mL is blue [NDC: 83616-107-01 (vial); NDC: 83616-107-11 (carton)]

Manufactured by: Replimune, Inc., 33 New York Ave Ste 100, Framingham, MA 01701

Marketed by: Replimune, Inc., 500 Unicorn Park Drive, Woburn, MA 01801

Drugs

Drug	Countries
TUDRIQEV	United States

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