Lukang Pharmaceutical announced that its controlling subsidiary Saite Company received the Drug Supplementary Application Approval Notice for Crisaborole Ointment issued by the National Medical Products Administration, approving Saite Company as the marketing authorization holder of the drug. The drug specification is 2 percent, 30 grams to 0.6 grams, indicated for topical treatment of mild to moderate atopic dermatitis in patients aged 3 months and older. The original drug was approved by the U.S. FDA in 2016. After the transfer, the production site, formulation, and manufacturing process remain consistent with the original drug, and the original drug approval number remains unchanged.
Shandong Lukang Pharmaceutical Co LtdSaite becomes marketing authorization holder for Crisaborole Ointment, expanding Lukang's product portfolio.
