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Celltrion gets FDA approval for antibiotic generic

By Maggie Lynch

- Last updated on GMT

(Image: Getty/Jarun011)
(Image: Getty/Jarun011)

Related tags: Celltrion, Antibiotic resistance

The South Korean company receives approval from the FDA for generic antibiotic, linezolid.

The US Food and Drug Administration (FDA) approved the sale of generic versions of linezolid produced by Celltrion, an oxazolidinone antibiotic for the treatment of infections such as streptococci, vancomycin-resistant enterococci, and methicillin-resistant Staphylococcus aureus (MRSA), with the drug working against infections caused by gram-positive bacteria.

Recently approved in Britain, linezolid was pre-qualified by the World Health Organization and can be used to treat infections of the skin and pneumonia among other drug-resistant tuberculosis. Currently, Pfizer markets the brand name linezolid, Zyvox, in the US.

Celltrion stated it will produce 3.6 million linezolid tablets this year and double production capacity by 2020.

The company currently possesses a portfolio of biosimilars, including Herzuma based on Roche’s Herceptin​ (trastuzumab) with Teva, and Truxima the first biosimilar to Rituxan (rituximab) for the treatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, and rheumatoid arthritis. However, in addition to its focus on biosimilars, Celltrion stated it had interest in entering the US generics market ​in 2017. 

Update: A previous version of this story incorrectly labeled Celltrion's approved product a biosimilar.

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