Jointly developed by Shanghai Institute of Materia Medica (SIMM), CAS and Anhui Global Pharmaceutical, Inc., Antofloxacin Hydrochloride and its tablets, a class one new drug, has been granted New Drug License and Drug Approval Certificate by State Food and Drug Administration (SFDA) recently.
Antofloxacin Hydrochloride is the first fluoroquinolone new drug from China with intellectual property right. The new drug is designed and developed by SIMM after over ten years’ research endeavor. Antofloxacin Hydrochloride is a new antibacterial drug with high safety and low toxic and side effects, superior to similar drugs currently available in the market. It shows significant therapeutic effect in treatments of dermatological, respiratory and urological infections.
In December 2003, Antofloxacin Hydrochloride and its tablets have been issued the new drug clinical trial approval by SFDA. Its Phase I clinical trial was completed in June 2004. The application for new drug license and drug approval certificate was submitted to SFDA after Phase II and Phase III clinical trials being completed in November 2006.