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Bayer, a leader in women's health, recently announced that it has submitted a new drug supplement application (sNDA) to the U.S. Food and Drug Administration (FDA) to extend the 52 mg life of its market-leading IUD Mirena (Chinese product name: Man-Moonle, Zurono progesterone IUD system).
, Mirena received FDA approval to extend the product's use to prevent pregnancy (contraception) for up to six years.
sNDA, based on the results of phase 3 extended trials assessing Mirena's effectiveness and safety, will seek to extend the use time by another year, with a maximum of seven years of pregnancy prevention.
Mirena, approved by the FDA in 2020, is the first hormone approved for use in the U.S. market and has now been approved to prevent pregnancy for up to six years by releasing a small amount of progesterone called zosterone progesterone into the womb.
the product is also the only FDA-approved IOD for women who have been treating IODs for up to five years, regardless of whether they have given birth before.
Mirena is a long-acting reversible contraceptive product (LARC) that can be removed at any time if a woman's plans change.
Mirena (zolenol progesterone in-house birth control system) 52 mg is used to prevent pregnancy for up to 6 years;
For women who choose to use IOD as a method of contraception, Mirena can be used to treat menstruation for up to 5 years;
Mirena is a small, soft T-shaped stent that slows the release of progesterone in the uterine cavity, and was approved in China in 1998 for use in contraception and idemotic months, with more than 100 million women worldwide.
, the State Drug Administration approved Mirena's adaptation update: "It's been a long time."
for structural monthly multiple patients, priority should be given to the treatment of primary diseases."
Mirena provides an effective non-surgical option for multiple treatment months.
original source: Bayer Submits Supplemental New Drug Application to FDA for Intrauterine Device (IUD) Mirena® (levonorgestrel-releasing intrauterine system) 52 mg Original title: Place once, contraception for 7 years! Bayer IDR Mirena (Man MoonLe) submits application in the U.S.: Extend the life limit! This article is sourced from Bio Valley, for more information please download Bio Valley APP (