It is the first time for Chinese pharmaceutical companies to submit new drug listing application to the United States

On March 5, Petrochemicals Group announced that it had successfully submitted a new drug listing application to the U.S FDA for L-amlodipine maleate tablets for the treatment of hypertension It is reported that this is the first time for Chinese pharmaceutical enterprises to submit a new drug listing application to the US FDA L-amlodipine is the enantiomer of (s) - amlodipine, the racemic mixture of (R) - and (s) - amlodipine Amlodipine is the third generation calcium channel blocker first developed by Pfizer In 1992, it was approved as Norvasc 2.5mg, 5.0mg and 10.0mg tablets in the United States for the treatment of hypertension L-amlodipine maleate tablets were 1.25 mg, 2.5 mg and 5.0 mg, respectively The tablets of L-amlodipine maleate (brand name: "Xuanning") have been sold in China since 2003 The clinical development of the drug in the United States is based on efficacy data and enhanced safety data from China After the pre application meeting with FDA in October 2018 and the completion of key clinical studies in December 2018, the new drug listing application of the drug has been successfully submitted The standard review time of new drug applications in the United States is about 12 months As one of the heavyweight products of Shiyao group, relying on the unique PCT patent splitting technology, Xuanning has successfully obtained one international invention patent and four domestic invention patents For Chinese pharmaceutical enterprises, it is not uncommon to complete the application for generic drug listing (anda), but there is no precedent to complete the application for new drug listing (NDA) This time, the new drug listing application submitted by Petrochemicals Group is a great leap forward in the process of internationalization development of Chinese Pharmaceutical enterprises.