Evaluation Summary of a kit for intrauterine insertion of Quinacrine Hydrochloride pellets for female sterilization. I. Background and Regulatory History: Quinacrine Hydrochloride (QH) tablets

Quinacrine Hydrochloride (QH) tablets were originally marketed in the United States in the early 1930s for the treatment of malaria. The drug was used extensively during World War II for this indication and was typically administered in a dose of 100-200 mg per day taken orally. In 1964, an injectable form of Quinacrine was approved for the treatment of recurrent ascites associated with several types of cancer. Marketing of both of these quinacrine products was subsequently discontinued (in July of 1994 for the oral tablets and in January of 1977 for the injectable formulation). Thus, there are no formulations of QH currently marketed in the United States.