A new drug of datoromycin for injection developed by Zhejiang Hisun Pharmaceutical Co.,ltd has been approved by the U.S. Food and Drug Administration(FDA). It means that the applicant can produce and sell the product in the U.S. market.
Daptomycin for injection is suitable for the treatment of: 1. Complex skin and skin structure infections (cSSSI) in adult and pediatric patients (1 to 17 years old); 2. Adult patients (including patients with right-sided infective endocarditis) Staphylococcus aureus bloodstream infection (bacteremia) in patients); 3. Staphylococcus aureus bloodstream infection (bacteremia) in pediatric patients (1 to 17 years old).
The approval of the daptomycin ANDA for injection by the US FDA signifies that the company has the qualification to sell the product in the US market, and has a positive impact on the company's expansion in the US market.