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FDA approves expanded indication for Liletta 6-year IUD

October 28, 2019 By Sean Whooley Leave a Comment

Medicines360 and its partner Allergan (NYSE:AGN) said today that the FDA approved Medicines360’s supplemental new drug application to extend the duration use of the Liletta intrauterine device for up to six years. The Liletta levonorgestrel-releasing intrauterine system now has the longest approved duration of use for a hormonal intrauterine device in the U.S., according to a […]

Filed Under: Drug-Device Combinations, Food & Drug Administration (FDA), Gynecological Tagged With: Allergan, FDA, Medicines360

FDA approves five-year hormonal contraceptive

October 16, 2018 By Sarah Faulkner Leave a Comment

Allergan (NYSE:AGN) and the nonprofit women’s health pharma company Medicines360 said today that the FDA approved an application to extend the duration of use for Liletta for the prevention of pregnancy for up to five years. Medicines360 first won approval for the levonorgestrel-releasing intrauterine device in February of 2015. The system’s latest FDA approval is based on a […]

Filed Under: Clinical Trials, Drug-Device Combinations, Food & Drug Administration (FDA), Pharmaceutical, Regulatory/Compliance, Wall Street Beat Tagged With: Allergan, Medicines360

Allergan touts 5-year data for Liletta intrauterine contraceptive

May 1, 2018 By Sarah Faulkner Leave a Comment

Allergan (NYSE:AGN) and its nonprofit partner, Medicines360, touted five-year data today from an on-going pivotal trial of its intrauterine device, Liletta. The levonorgestrel-releasing contraceptive is approved in the U.S. to be used to prevent pregnancy for up to four years. Get the full story at our sister site, Drug Delivery Business News.

Filed Under: Clinical Trials, Drug-Device Combinations, Pharmaceutical, Wall Street Beat, Women's Health Tagged With: Allergan, Medicines360

FDA approves 4-year intrauterine device

August 7, 2017 By Sarah Faulkner Leave a Comment

Allergan (NYSE:AGN) and women’s health nonprofit Medicines360 said today that the FDA approved a supplemental new drug application to extend the duration of use for Liletta, a levonorgestrel-releasing intrauterine device, for up to four years. The hormone-releasing device was first approved in February 2015 and it won additional approval in January last year for a single-handed inserter. Get […]

Filed Under: Drug-Device Combinations, Food & Drug Administration (FDA), Pharmaceutical, Regulatory/Compliance, Wall Street Beat Tagged With: Allergan, Medicines360

Allergan, Medicines360 tout 4-year pivotal data for Liletta intrauterine contraceptive

May 9, 2017 By Sarah Faulkner Leave a Comment

Allergan (NYSE:AGN) and women’s health nonprofit pharma company Medicines360 touted 4-year data today from an ongoing pivotal trial for its Liletta intrauterine contraceptive. The system is approved for the prevention of pregnancy for up to 3 years. More than 1,500 women ranging from 16 to 45 years old were enrolled and studied in the group’s […]

Filed Under: Clinical Trials, Drug-Device Combinations, Gynecological, MassDevice Earnings Roundup, Pharmaceutical, Wall Street Beat, Women's Health Tagged With: Allergan, Medicines360

FDA accepts Allergan’s new drug application for Liletta contraception device

January 4, 2017 By Sarah Faulkner Leave a Comment

Allergan (NYSE:AGN) and the global nonprofit women’s health company Medicines360 said today that the FDA accepted its supplemental New Drug Application for the Liletta contraception device. The companies are asking the federal watchdog to extend the system’s duration of use from 3 years to 4 years. Liletta is a levonorgestrel-releasing intrauterine system that is placed […]

Filed Under: Drug-Device Combinations, Food & Drug Administration (FDA), Gynecological, Pharmaceutical, Regulatory/Compliance, Women's Health Tagged With: Allergan, Medicines360

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