China Aoxing has submitted a new drug application (NDA) to the China State Food and Drug Administration (SFDA) for its Codeine Phosphate, a compound oral solution for the treatment of acute moderate to severe cough.
Under the regulation of the China SFDA, the drug is designated as a Class III New Medicine, or the first drug to be launched in China while already selling in other regulated territories.
Reportedly, the product is expected to receive at least three-year market exclusivity protection after marketing clearance by the China SFDA.
In June 2009, China Aoxing has announced that it had completed the clinical studies required for an NDA by the China SFDA. Assuming timely regulatory approval, the company expects to launch the product in China in 2010.
Zhenjiang Yue, chairman and CEO of China Aoxing, said: “This is a major achievement of our company. We believe that this drug will address a growing and presently unserved need in the marketplace, and we are very hopeful that the SFDA will find our submission acceptable for final production approval. We believe that we have adhered to the requirements we agreed upon with the SFDA at our pre-NDA meeting. We are also very pleased with the tremendous team effort, great planning and execution by our own staff.”