FDA approves Actavis' reversible contraceptive device
{{#rendered}} {{/rendered}}The U.S. Food and Drug Administration approved a hormonal contraceptive device on Friday that gives American women another reversible contraceptive choice as effective as sterilization.
Actavis Plc holds the commercial license to the device, Liletta. The marketing application was submitted by non-profit pharmaceutical company Medicines360, which holds the U.S. public sector clinic rights.
Actavis and Medicines360 expect the device to be available for use in the United States by the second quarter of 2015.
{{#rendered}} {{/rendered}}Typically smaller than an iPod Shuffle, the hormonal intrauterine device (IUD) is a t-shaped piece of plastic that must be inserted into the uterus to prevent fertilization.
Liletta releases the hormone levonorgestrel to inhibit thickening of the womb lining, preventing pregnancy for up to three years.
The plastic device also helps to check heavy menstrual bleeding.
{{#rendered}} {{/rendered}}Hormonal UIDs are marginally more effective than commonly used copper IUDs such as Teva Pharmaceutical Industry Ltd's Paragard, which last longer but provide no blood flow control.
The Actavis device will compete in the $1 billion global market for UIDs, said Michael WaterHouse, an analyst at brokerage Morningstar.
WaterHouse estimates peak sales of below $500 million globally for the device.
{{#rendered}} {{/rendered}}The device, which is already used in Europe, will also compete with Bayer AG's hormonal IUDs Mirena and Skyla in the United States.
While existing devices offer between three and 12 years of protection, Liletta is approved for use for up to three years.