Liletta Approved to Prevent Pregnancy for up to Four Years
The FDA's approval of the supplemental New Drug Application (sNDA) was based on efficacy and safety data from the ongoing Phase 3 ACCESS IUS trial (n=1,751). The study showed Liletta was >99% effective in preventing pregnancy across a varied demographic with differing age, body mass index, parity, and race.
Liletta, a hormone-releasing system, was initially approved in February 2015 for the prevention of pregnancy for up to 3 years. It gained additional FDA approval in January 2016 for the single-handed inserter.
"IUDs are among the safest and most effective forms of contraception and are a critical tool in reducing unintended pregnancy. As a clinician, I appreciate that the clinical trial demonstrated Liletta's safety and efficacy across a wide range of women, regardless of age, BMI and ethnicity," said Dr. David Turok, Associate Professor, University of Utah Department of Obstetrics and Gynecology.
Liletta is supplied as a 52mg strength system as a single- or two-handed inserter.
For more information call (800) 678-1605 or visit Liletta.com.