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Findings of First-Year Post-Marketing Pharmacovigilance in ACOG Poster Presentation","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2022","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Approved"},{"orgOrder":0,"company":"TherapeuticsMD","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"TherapeuticsMD Receives U.S. Food and Drug Administration (FDA) Approval for Supplemental New Drug Application (sNDA) for ANNOVERA\u00ae","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2022","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s 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Find Clinical Drug Pipeline Developments & Deals for PREVIFEM
The net proceeds will be used for the Twirla (levonorgestrel and ethinyl estradiol), the first and only combined hormonal once-weekly birth control patch delivering a low dose of estrogen.
The agreement aims to expand patient access and streamline fulfillment for Twirla (levonorgestrel ethinyl estradiol) transdermal system, a once-weekly combined hormonal contraceptive (CHC) patch, indicated for use as a method of contraception by women.
TWIRLA is a combination of levonorgestrel, a progestin, ethinyl estradiol and estrogen. It is a hormonal contraceptives lower the risk of becoming pregnant primarily by suppressing ovulation.
The combination will create one of the largest and fastest growing UK pharma companies and accelerated growth in current and future product portfolio, especially in healthcare (leading asset Akizza having gestodene/ethinylestradiol combination) in the UK and internationally.
TherapeuticsMD has three growing assets whose value has been enhanced by the recent approval of both Annovera’s (segesterone acetate) supplemental NDA and lower-dose Bijuva, as well as the increasing relevance of convenient and safe contraceptive options for women.
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.
The sNDA included minor revisions to Annovera (segesterone acetate) in vitro release testing specification that allowed for normal manufacturing variability, was approved by the FDA in August 2018 as the only long-lasting, reversible, procedure-free birth control.
Approval of Twirla (levonorgestrel) was based on SECURE study, which demonstrated safety in a large diverse group of women in a clinical trial setting.
U.S.FDA has approved Abbreviated New Drug Application for Merzee (Slayback Pharma), an AB-rated generic equivalent of Taytulla® (Allergan), an estrogen/progestin combination oral contraceptive indicated for use by women to prevent pregnancy.
Twirla (levonorgestrel and ethinyl estradiol) transdermal system is combined hormonal contraceptive patch, indicated for use as a method of contraception by women of reproductive potential with a body mass index < 30 kg/m2.
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