Estradiol

The FDA sent the untitled letter on April 28 and gave Mayne 15 working days to respond. Mayne Pharma is in trouble with the FDA. The agency has accused the Australian pharma of giving a misleading impression of the risks of its oral birth control pill in a presentation, triggering an untitled letter (PDF).FDA officials sent the letter after reviewing a slide deck (PDF) about Mayne’s contraceptive medication Nextstellis. The FDA claimed the presentation minimized the risks associated with Nextstellis and misrepresented how the drug compares to rival estrogen-containing combined hormonal contraceptives. Those failings are particularly concerning, according to the agency, because Nextstellis is linked to potentially life-threatening risks. The FDA said the deck contains “misleading” claims that estetrol, one of the active ingredients in Nextstellis, is unique and intrinsically different from other estrogens. For example, claims that estetrol is “low impact” and has “minimal effect on the liver” suggest Nextstellis is safer than other estrogen-containing oral contraceptives, the FDA said, but that has “not been demonstrated.”Sections of the deck deal specifically with the effect of Nextstellis on breast and liver tissue. One slide compares the “slow, extensive” hepatic metabolism of ethinyl estradiol, another estrogen commonly used in birth control pills, to the “minimal” hepatic metabolism of estetrol. The FDA said the slide misleadingly suggests estetrol has safety advantages over ethinyl estradiol.Other slides say estetrol has “a low impact on breast tissue” and “does not stimulate breast tissue.” The FDA said the slides add to the misleading impression about the comparative safety of Nextstellis and rival oral contraceptives.“These claims suggest that Nextstellis is a safer option for patients who have or have had breast cancer when, in fact, Nextstellis is contraindicated in patients with a current diagnosis or history of breast cancer, which may be sensitive to female hormones,” the FDA said. The FDA sent the untitled letter on April 28 and gave Mayne 15 working days to respond in writing. Mayne did not immediately respond to Fierce Pharma Marketing’s request for comment.Nextstellis has been approved in the U.S. since 2021, when its estetrol became the first new estrogen introduced in the country in over half a century, per the company. Just a week before the FDA sent the letter, in an April 22 business update, Mayne reported (PDF) lower-than-expected volumes of Nextstellis, even as net sales for its overall women’s health segment grew 8% year over year.Cosette Pharmaceuticals agreed to buy Mayne for $430 million in February. Cosette satisfied (PDF) one of the takeover closing conditions last week, keeping it on track to complete the deal in June or July.

PRINCETON, NJ, May 13, 2025 /PRNewswire/ - Duchesnay USA, a specialty pharmaceutical company dedicated to women's health and part of Duchesnay Pharmaceutical Group (DPG), is pleased to announce a strategic partnership with MyMenopauseRx, a virtual doctor's office dedicated to offering high-quality specialists consultations that expand access to care for women transitioning through menopause. Continue Reading Duchesnay USA and MyMenopauseRx join in a partnership (CNW Group/Duchesnay USA) This collaboration aims to bridge the healthcare gap that exists in this often overlooked area. Through this initiative, women will have insurance-covered access to board-certified menopause specialists at any time from the 26 states MyMenopauseRx currently serves, with more states coming soon. "With women's well-being at the heart of our philosophy, we, at Duchesnay USA, believe that menopausal women deserve the same level of attention, care, and innovation as any other patient population," said Tanya Carro, Executive Vice President, U.S. Entities. "This partnership combines Duchesnay USA's commitment to research and innovation with MyMenopauseRx's deep expertise in the treatment of menopausal symptoms, ensuring that more women can rely on expert care when and where they need it." Founded by Dr. Barbra Hanna, a board-certified gynecologist and Menopause Society Certified Practitioner, MyMenopauseRx offers FDA-approved therapies and board-certified guidance backed by science through telehealth visits that are covered by most major health insurance plans. "Navigating menopause can be incredibly challenging because it's often misunderstood and under-discussed. Many women face stigma when speaking openly about their symptoms, struggle to find clinicians with specialized training, and are left without clear guidance on evidence-based treatments," said Dr. Barbra Hanna, founder of MyMenopauseRx. "By partnering with Duchesnay USA, we aim to empower women with the knowledge and expert care to transition this stage of life with confidence." MyMenopauseRx menopause specialist consultations are available through the Osphena website. IMPORTANT SAFETY INFORMATION Indication: What is Osphena® (ospemifene)? Osphena is a prescription oral pill that treats moderate to severe painful intercourse and/or moderate to severe vaginal dryness, both symptoms of changes in your vagina, due to menopause. BOXED WARNING: ENDOMETRIAL CANCER AND CARDIOVASCULAR DISORDERS Osphena® works like estrogen in the lining of the uterus (endometrium), but can work differently in other parts of the body. Taking estrogen alone or Osphena® may increase your chance for getting cancer of the lining of the uterus. Vaginal bleeding after menopause may be a warning sign of cancer of the lining of the uterus. Your healthcare provider should check any unusual vaginal bleeding to find out the cause, so tell him or her right away if this happens while you are using Osphena® . Osphena® may increase your chances of having a stroke or blood clots. You and your healthcare provider should talk regularly about whether you still need treatment with Osphena® . Most Important Information you should know about Osphena® Call your healthcare provider right away if you have unusual vaginal bleeding, changes in vision or speech, sudden new severe headaches, and pains in your chest or legs with or without shortness of breath, weakness and fatigue. Who should not take OSPHENA? Osphena® should not be used if you have unusual vaginal bleeding, have had certain types of cancers, have or have had blood clots, had a stroke or heart attack, have severe liver problems, are allergic to Osphena® or any of its ingredients, or think you may be pregnant. Tell your healthcare provider if you are going to have surgery or will be on bed rest. POSSIBLE SIDE EFFECTS Serious but less common side effects can include: stroke, blood clots and cancer of the lining of the uterus. Less serious, but common side effects include: hot flushes or flashes, vaginal discharge, muscle spasms, headache, excessive sweating (hyperhidrosis), heavy vaginal bleeding (vaginal hemorrhage), night sweats Tell your healthcare provider about all of the medicines and supplements you take, as some medicines may affect how Osphena® works. Osphena® may also affect how other medicines work. Duchesnay USA encourages you to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. Please read accompanying Patient Information for Osphena®(ospemifene) tablets, including Boxed Warning in the U.S. Full Prescribing Information. ABOUT DUCHESNAY USA Duchesnay USA is a specialty pharmaceutical company with a long-standing commitment to women's health. The company focuses on filling the void in terms of scientific research and education and on developing pharmacological solutions that are safe and effective for use during pregnancy and breastfeeding. Duchesnay USA also commercializes a broad portfolio of products to offer safe and effective therapeutic options that meet the health and quality of life needs of women and their family members at various stages of their lives. For more information, please visit: . Follow us on LinkedIn. ABOUT DUCHESNAY PHARMACEUTICAL GROUP Duchesnay Pharmaceutical Group (DPG), with its affiliated companies, is headquartered in Blainville, Quebec. The Group consists of six pharmaceutical companies to meet the needs of patients in Canada, the U.S. and abroad. The companies are Duchesnay (Canada) and Duchesnay USA, both dedicated to women's health; Medunik Canada and Medunik USA, which provide treatments for rare and debilitating diseases; and Analog Pharma Canada and Analog Pharma, specializing in orphan generic medications. From its state-of-the-art manufacturing plant, DPG exports its innovative treatments to more than 50 countries. DPG is one of the eight companies across the country chosen to participate in the Government of Canada's Global Hypergrowth Project. This appointment offers exclusive and personalized support for at least two years, in order to accelerate its growth to become an anchor firm in the Canadian economy. DPG is the winner of the 2024 Life Sciences Innovation Award by ADRIQ, the Association for the Development of Research and Innovation of Quebec, which recognizes DPG's healthy workplace culture and commitment to pharmaceutical innovation, while DPG president Éric Gervais is the recipient of the 2024 Bernard-Landry Award by ADRIQ which acknowledges his impactful leadership on Quebec's research and innovation ecosystem. DPG, through its proprietary research and development, and through exclusive partnerships, offers innovative treatments for a variety of medical conditions in women's health, urology, oncology and for rare diseases, plus lower-cost generic medications. DPG recognizes the dedication and professionalism of its employees and promotes a positive culture and flexible work environment. It is deeply committed to environmental responsibility and to giving back to the community through the support of various charitable organizations. For more information, please visit . Follow us on LinkedIn. About MyMenopauseRx MyMenopauseRx was founded by Dr. Barbra Hanna, DO, FACOG, MSCP, with the mission to empower women with access to high-quality virtual menopause care, covered by health insurance, so they can live their best lives. As a virtual doctor's office and telemedicine platform, MyMenopauseRx specializes in personalized care for women navigating perimenopause and menopause. Virtual appointments with menopause society-certified practitioners are available in an increasing number of states across the U.S., making expert care more accessible than ever. For more information, visit . SOURCE Duchesnay USA WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED