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Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Glenmark Pharmaceuticals receives ANDA approval for Norethindrone Acetate and Ethinyl Estradiol Capsules and Ferrous Fumarate Capsules, 1 mg\/20 mcg","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"July 2022","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Approved"},{"orgOrder":0,"company":"Myovant Sciences","sponsor":"Pfizer Inc","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Myovant Sciences and Pfizer Receive U.S. FDA Approval of MYFEMBREE\u00ae, a Once-Daily Treatment for the Management of Moderate to Severe Pain Associated With Endometriosis","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"August 2022","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Approved"},{"orgOrder":0,"company":"Gedeon Richter","sponsor":"Sumitomo","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Gedeon Richter and Sumitomo Pharma Receive Positive CHMP Opinion for RYEQO\u00ae for Treatment of Endometriosis","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Phase III","country":"HUNGARY","productType":"Small molecule","productStatus":"Approved","date":"September 2023","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Phase III"},{"orgOrder":0,"company":"Sumitomo","sponsor":"Pfizer Inc","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Sumitomo Pharma and Pfizer in Canada Receive Health Canada Approval for MYFEMBREE\u00ae","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Approved","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"October 2023","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Approved"},{"orgOrder":0,"company":"Gedeon Richter","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"European Commission Approves the Commercialisation of RYEQO\u00ae for the Symptomatic Treatment of Endometriosis","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Approved","country":"HUNGARY","productType":"Small molecule","productStatus":"Approved","date":"November 2023","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Approved"}]
Find Clinical Drug Pipeline Developments & Deals for Norethindrone Acetate
Ryeqo (relugolix, estradiol, and norethisterone acetate) receives approval from EU in for the adjuvant treatment of endometriosis in women with a history of previous medical or surgical treatment for their endometriosis.
Myfembree (relugolix, estradiol, and norethindrone acetate) has received a dual indication approval, making it the first Health Canada-approved oral treatment to manage uterine fibroids and endometriosis.
Ryeqo (relugolix, estradiol, and norethisterone acetate) receives positive opinion by CHMP recommending approval in for the adjuvant treatment of endometriosis in women with a history of previous medical or surgical treatment for their endometriosis.
MYFEMBREE (relugolix, estradiol, and norethindrone acetate) is a once-daily oral treatment approved by the U.S. Food and Drug Administration for the management of moderate to severe pain associated with endometriosis, with a treatment duration of up to 24 months.
The generic version of Taytulla®1 Capsules, Norethindrone Acetate and Ethinyl Estradiol Capsules and Ferrous Fumarate Capsules, 1 mg/20 mcg, has received approval by the United States Food & Drug Administration.
MYFEMBREE (relugolix, estradiol, and norethindrone acetate) is first and only once-daily oral treatment for heavy menstrual bleeding associated with uterine fibroids in premenopausal women approved by USFDA with a treatment duration of up to 24 months.
The sNDA proposes updates to MYFEMBREE (Relugolix) based on safety and efficacy data from the Phase 3 LIBERTY randomized withdrawal study of MYFEMBREE in premenopausal women with heavy menstrual bleeding associated with uterine fibroids for up to two years.
Results demonstrated that OBE-2109 (linzagolix) has potential to balance safety, efficacy, and address wide-ranging symptoms of uterine fibroids also showed promise in delivering sustained clinical benefit.
MYFEMBREE (relugolix, estradiol, and norethindrone acetate) is first once-daily oral treatment for heavy menstrual bleeding associated with uterine fibroids in premenopausal women approved by U.S. FDA, with a treatment duration of up to 24 months.
MYFEMBREE (relugolix, estradiol, and norethindrone acetate) is the first once-daily oral treatment for heavy menstrual bleeding associated with uterine fibroids in premenopausal women approved by U.S. Food and Drug Administration, with a treatment duration of upto 24 months.
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