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CSPC's L-Amlodipine maleate is approved by the FDA

Posted: December 20, 2019 Posted by: CSPC


On December 20, CSPC announced that the US Food and Drug Administration (FDA) has approved CONJUPRI® (Levamlodipine Maleate) tablets for the marketing of new drugs (NDA) for the treatment of hypertension. According to the currently known data, this is the first Chinese pharmaceutical company to submit a new drug listing application to the US FDA and has passed the normal FDA approval process, becoming the first Chinese innovative drug to be fully approved by the FDA.

L-Amlodipine is an enantiomer of pharmacological activity in purified (S) -amlodipine, a racemic mixture of (A)-and (S) -amlodipine, used in the treatment of hypertension. Constituency. Amlodipine is a third-generation calcium channel blocker first developed by Pfizer in 1992 and marketed as NORVASC® (amlodipine besylate) 2.5 mg, 5.0 mg, and 10.0 mg tablets. The approved CONJUPRI® (levamlodipine maleate) tablets are 1.25 mg, 2.5 mg and 5.0 mg.

CSPC has been promoting the sales of L-Amlodipine Maleate (trade name: Xuanning) in China since 2003. The clinical development of L-Amlodipine maleate in the United States is based on Chinese safety and efficacy data, and data showing that L-Amlodipine has fewer adverse reactions than amlodipine.

FDA's approval allows CSPC to sell CONJUPRI® in the United States, and also promotes sales in other parts of the world. As the first FDA-approved L-Amlodipine, CONJUPRI® is eligible to become a reference preparation for drugs with the same active ingredients .

L-Amlodipine maleate tablets were approved for new drugs in the United States, demonstrating CSPC's determination to innovate and provide the best drugs to patients worldwide.