Sunny Secures FDA ANDA Approval for Phytonadione Injection for the U.S. Market
Sunny has received U.S. FDA approval and obtained the Abbreviated New Drug Application (ANDA) on January 9th, 2026, for its generic Phytonadione Injectable Emulsion USP. Indicated for the treatment of Vitamin K1 deficiency. The product will be marketed in the United States through Sunny’s local partner. According to IQVIA data, the annual sales in the U.S. reached approximately USD 13 million.