October 6, 2000 WASHINGTON (AP) - The Food and Drug Administration approved a new form of birth control Thursday - a monthly shot to prevent pregnancy.
Lunelle, made by Pharmacia Corp. of Peapack, N.J., is more than 99 percent effective when women get the shot once every month, company studies concluded.
The FDA cautioned that women cannot go longer than 33 days between shots, or they will need a pregnancy test before the next injection. The shots must be administered by a health care provider.
Lunelle is an alternative to another injectable contraceptive called Depo-Provera that lasts three months. Like many birth control pills, it works through a combination of the hormones progestin and estrogen.
Lunelle should be on the market by the end of the year, and cost $30 to $37 a shot, Pharmacia spokeswoman Kristin Elliott said.
Lunelle was approved based on data from a clinical study of 1,103 women at 42 sites in the United States. The study compared patients taking Lunelle to those on Ortho-Novum 7/7/7, a common birth control pill.
The 783 women taking Lunelle had no unintended pregnancies, though there were two among the 321 women using the oral contraceptive after 15 cycles of use.
Women taking the contraceptive injection still have monthly menstrual cycles. There also is a quick return to ovulation, usually within two to four months, Pharmacia said. More than 50 percent of users became pregnant within six months of quitting Lunelle.
Copyright 2000 The Associated Press. All rights reserved.
