Combined hormonal contraceptives

TherapeuticsMD Announces Poster Presentation of ANNOVERA® Data at the American College of Obstetricians and Gynecologists 2021 Annual Meeting

Retrieved on: 
Monday, May 3, 2021

In clinical studies, ANNOVERA showed predictable scheduled bleeding for most women.

Key Points: 
  • In clinical studies, ANNOVERA showed predictable scheduled bleeding for most women.
  • Bleeding data were available from 2,070 women a total of 453,622 patient-days evaluated for bleeding.
  • The daily percentage of women presenting unscheduled bleeding (\xe2\x89\xa41.4%) or spotting (\xe2\x89\xa43.6%) was consistently low throughout the 13 cycles of ANNOVERA use.
  • Call your healthcare provider or get emergency medical care right away if any of these serious side effects occur.\nThe most common side effects of ANNOVERA include:\n'

Amneal Receives Approval for Generic Version of Ortho Evra®

Retrieved on: 
Friday, February 26, 2021

In conjunction with its approval, Amneal received a Competitive Generic Therapy (CGT) designation by the FDA and has been granted 180 days of exclusivity.

Key Points: 
  • In conjunction with its approval, Amneal received a Competitive Generic Therapy (CGT) designation by the FDA and has been granted 180 days of exclusivity.
  • Amneals Norelgestromin and Ethinyl Estradiol Transdermal System is the generic version of the reference listed drug (RLD) Ortho Evra and will be marketed under the proprietary name Zafemy.
  • Todays approval is a significant milestone for patients and our company, said Chirag and Chintu Patel, Co-Chief Executive Officers.
  • Xulane is the only other equivalent to Ortho Evra currently available on the market.

Agile Therapeutics Announces Nationwide Commercial Launch and Availability of Twirla® (levonorgestrel and ethinyl estradiol) Transdermal System, a New Non-Daily, Non-Invasive Contraceptive Patch

Retrieved on: 
Monday, December 7, 2020

Twirla is designed to be worn on the abdomen, buttock, or upper torso (excluding the breasts), using Skinfusion technology.

Key Points: 
  • Twirla is designed to be worn on the abdomen, buttock, or upper torso (excluding the breasts), using Skinfusion technology.
  • At less than 1mm thin, Twirla is made up of five distinct layers for focused drug delivery and to help maintain adhesion.
  • I am excited that healthcare providers can now offer a new solution that can fill a gap in hormonal contraceptive care.
  • Twirla patients can access the Twirla patch replacement program, chat with qualified nurse-educators about patch use, and read specially curated content designed to inspire Twirla women beyond the brand.

Population Council and Duchesnay Announce New International License Agreement for ANNOVERA®

Retrieved on: 
Monday, November 30, 2020

This agreement is another step toward bringing contraceptive choice, convenience and control to women around the world.

Key Points: 
  • This agreement is another step toward bringing contraceptive choice, convenience and control to women around the world.
  • ANNOVERA was approved by the U.S. Food and Drug Administration (FDA) in August 2018 and is now available to women in the United States.
  • As part of the agreement, Duchesnay will explore opportunities to register ANNOVERA with local regulatory agencies in these regions and will invest in the Population Council's research activities to develop new innovative contraceptive products.
  • Established in 1952 and headquartered in New York, the Council is a nongovernmental, non-profit organization governed by an international board of trustees.

Population Council and Duchesnay Announce New International License Agreement for ANNOVERA®

Retrieved on: 
Monday, November 30, 2020

This agreement is another step toward bringing contraceptive choice, convenience and control to women around the world.

Key Points: 
  • This agreement is another step toward bringing contraceptive choice, convenience and control to women around the world.
  • ANNOVERA was approved by the U.S. Food and Drug Administration (FDA) in August 2018 and is now available to women in the United States.
  • As part of the agreement, Duchesnay will explore opportunities to register ANNOVERA with local regulatory agencies in these regions and will invest in the Population Council's research activities to develop new innovative contraceptive products.
  • Established in 1952 and headquartered in New York, the Council is a nongovernmental, non-profit organization governed by an international board of trustees.