Nypozi — licensed biologic

Overview

Source: Purple Book

Proprietary name

Nypozi

Proper name

filgrastim-txid

Licence type

351(k) Biosimilar

BLA number

761126

Applicant

Tanvex BioPharma USA, Inc.

Center

CDER

Presentations

2

First licensure

—

351(k) biosimilar pathway. This product was licensed as highly similar to a reference product, with no clinically meaningful differences in safety, purity or potency. It is licensed as a biosimilar but is not designated interchangeable, so substitution requires the prescriber.

Presentations

Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
300MCG/0.5ML	Injection	Intravenous, Subcutaneous	Pre-Filled Syringe	Rx	June 28, 2024
480MCG/0.8ML	Injection	Intravenous, Subcutaneous	Pre-Filled Syringe	Rx	June 28, 2024

Reference product

Source: Purple Book

This product is licensed with reference to Neupogen (filgrastim).

View reference product Search the small-molecule catalogue

Sources for this page

Purple Book	FDA	Licence type, presentations, reference product, exclusivity