Zhitong Finance App News, ST Notch (688076.SH) issued an announcement. Recently, the company received a notice from the US Food and Drug Administration (“FDA”) that the company submitted to the US FDA for a simplified new drug application (“ANDA” for short) has been approved for marketing by the US FDA. The US FDA carried out a comprehensive technical review of the ANDA application data submitted by the company for fluravicin injection, and determined that the company's product was bioequivalent and curative equivalent to the original drug. This drug is the company's first pharmaceutical product approved in the US. It marks a landmark achievement for the company's pharmaceutical products going overseas, and has had a positive impact on increasing international sales of pharmaceutical products.

Zhitongcaijing · 2d ago
Zhitong Finance App News, ST Notch (688076.SH) issued an announcement. Recently, the company received a notice from the US Food and Drug Administration (“FDA”) that the company submitted to the US FDA for a simplified new drug application (“ANDA” for short) has been approved for marketing by the US FDA. The US FDA carried out a comprehensive technical review of the ANDA application data submitted by the company for fluravicin injection, and determined that the company's product was bioequivalent and curative equivalent to the original drug. This drug is the company's first pharmaceutical product approved in the US. It marks a landmark achievement for the company's pharmaceutical products going overseas, and has had a positive impact on increasing international sales of pharmaceutical products.