[ET Net News Agency, 20 December 2019] CSPC Pharmaceutical Group Limited (01093)
announced that CONJUPRI (levoamlodipine maleate) tablets have received marketing approval
from the U.S. Food and Drug Administration (FDA) for the treatment of hypertension. This
is the first New Drug Application (NDA) ever submitted to the FDA by Chinese
pharmaceutical companies, and now granted full approval following a standard review by the
FDA.
This NDA approval allows the group to market CONJUPRI in the U.S. and also paves the way
for marketing in other parts of the world. As the first levoamlodipine approved by the
FDA, CONJUPRI is qualified to be the reference standard for drugs with the same active
ingredient. (RC)