Advisory Committee for Reproductive Health Drugs

Advisory Committee for Reproductive Health Drugs
Meeting on January 20, 2012, from 8 a.m. to 4:30 p.m.

AGENDA DESC Agenda: The committee will discuss the benefits and risks of new drug application 22–139, progesterone gel 8%, Columbia Laboratories, Inc., for the proposed indication of ‘‘reduction of risk of preterm birth in women with short uterine cervical length regardless of other risk factors in the mid-trimester of pregnancy.’’ The uterine cervix is the mouth of the uterus (or womb) leading into the vagina (or birth canal). The benefit/risk discussion will focus on the adequacy of the demonstration of efficacy in the U.S. population.