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The JNDA for the product is mainly based on positive data from the phase three programme conducted in Japan.
The JNDA for daprodustat is primarily based on positive data from the phase 3 programme conducted in Japan.
In July, Mitsubishi Tanabe Pharma Corporation (MTPC), Akebia's development and commercialization collaboration partner in Japan for vadadustat, submitted a Japanese New Drug Application (JNDA) to the Ministry of Health, Labor and Welfare in Japan for manufacturing and marketing approval of vadadustat as a treatment for anemia due to CKD.
In light of the JNDA submission, as well as the current timeline, Arce pushed back his U.S.
The JNDA is the first regulatory submission for marketing approval of vadadustat and, if approved, is expected to lead to the first launch of vadadustat worldwide.
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