Zhejiang Xianju Pharmaceutical Co.,Ltd. (002332.SZ) has announced that its Abbreviated New Drug Application (ANDA) for progesterone vaginal tablets has been formally accepted for review by the U.S. Food and Drug Administration (FDA).
The company confirmed it recently received the official notification from the US regulator regarding the acceptance of its registration filing.
The progesterone vaginal tablet is indicated for luteal phase support in assisted reproductive technology (ART), aiming to supplement luteal function to facilitate embryo implantation and support early pregnancy.