Introduction
Indication: Neutropenia
Originator: Amgen (brand name Neupogen®)
1. Development status in Canada
- Marketing Authorization granted in 2021
- Drug Establishment License (DEL) received from Health Canada in 2022
- Distribution partner: Sandoz
2. Development status in USA
BLA filed. CRL received in 2023. Resubmission in April 2023
Features / strengths
1. Receiving Drug Establishment License (DEL) from Health Canada in 2022
2. Distribution partner in Canada: Sandoz
3. Manufactured in USA
4. US FDA drug approval: in process
Specification in detail
