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Ethinylestradiol/levonorgestrel transdermal - Agile Therapeutics

Drug Profile

Ethinylestradiol/levonorgestrel transdermal - Agile Therapeutics

Alternative Names: AG 200 ER; AG 200 ER (SmP); AG 200 SP; AG-200-15; Ethinyl estradiol and levonorgestrel transdermal system; Low dose EE/LNG; Twirla

Latest Information Update: 26 Jun 2019

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At a glance

  • Originator Agile Therapeutics
  • Class Alkylated estrogenic steroids; Contraceptives; Hormonal replacements; Norpregnanes; Norpregnatrienes; Small molecules
  • Mechanism of Action Estrogen receptor agonists; Progesterone receptor agonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity No

Highest Development Phases

  • Preregistration Pregnancy

Most Recent Events

  • 24 Jun 2019 Agile Therapeutics plans a meeting with the US FDA to review the NDA of Ethinylestradiol/levonorgestrel transdermal for Pregnancy (Prevention)
  • 24 Jun 2019 FDA assigns PDUFA action date of 16/11/2019 for Ethinylestradiol/levonorgestrel transdermal for Pregnancy (Prevention)
  • 16 May 2019 Agile Therapeutics re-submits the NDA to the US FDA for Pregnancy (Prevention)
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