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2024-04-16

Kindos creates the new record for fastest approval by FDA: Dacarbazine for Injection

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On April 3, 2024, Dacarbazine for Injection of Kindos Pharmaceuticals Co., Ltd.(Subsidiary of Nanjing Kingfriend) got approved for commercial sale by US FDA via conditional accelerated approval.

 

Dacarbazine for Injection, having numerous focuses from FDA due to the shortage in US, is used to treat melanoma and Hodgkin's lymphoma. Based on the fine and consistent compliance of Kindos(Subsidiary of Nanjing Kingfriend) and adequate trust for its team, FDA proactively contacted Kindos(Subsidiary of Nanjing Kingfriend) when FDA found Kindos(Subsidiary of Nanjing Kingfriend) planned to apply for this product in November 2023 and then granted access for faster track so as to accelerate the marketing of Dacarbazine for Injection.



With assistance from FDA, Kindos(Subsidiary of Nanjing Kingfriend) team promptly modified the project plan and optimized the work procedure while ensuring the compliance with regulations and successfully achieving each milestone target of every stage. Finally, the period from submitting application to getting approval was over 50% shorter than normal time spent in pharmaceutical industry and this whole process created the new record for fastest approval in Kindos’(Subsidiary of Nanjing Kingfriend) history.


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    Reference linking| https://mp.weixin.qq.com/s/m4ICbDLyqL7Z_jsxUflUCg