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 ((R)-and (S) -amlodipine) for the treatment of hypertension. Construct. 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 levoridipine, CONJUPRI® is eligible to become a reference preparation for drugs with the same active ingredients .
Levomlodipine maleate tablets have been approved for new drug marketing in the United States, demonstrating CSPC's commitment to innovate and provide the best drugs to patients worldwide.