Clinical approval for tenofovir dipivoxil fumarate, a new drug of Anke in the treatment of AIDS

Tenofovir fumarate dipivoxil (tablets) is a nucleotide reverse transcriptase inhibitor, which is mainly used in the treatment of AIDS, hepatitis B and other diseases The drug was first developed by Gilead company in the United States At present, only one original manufacturer of this kind of tablet in China has obtained import registration and marketing According to the notice of approval opinions of the State Food and Drug Administration on tenofovir fumarate Dipivoxil and the approval documents of clinical trials of tenofovir fumarate dipivoxil tablets The dosage form of the drug is approved as API and tablet, and the registration classification is: chemical 3.1 and chemical 3.4 After obtaining the approval for clinical trial of tenofovir dipivoxil fumarate tablets, the company will organize and implement the clinical trial according to the requirements of the national clinical trial, and apply for the production approval of this product after the completion of the clinical trial According to the insiders, there are many uncertainties in the process from clinical trial to formal production with national approval The time is short for several months, long for several years, or even premature.