WALTHAM, Mass., October 29, 2019 – AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced that NASDAQ has halted trading of the company’s common stock. The U.S. Food and Drug Administration (FDA) Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) is meeting today to better understand and interpret the PROLONG (Progestin’s Role in Optimizing Neonatal Gestation) trial data for Makena® (hydroxyprogesterone caproate injection). The advisory committee meeting is scheduled to start at 8:15 a.m. ET. The briefing materials may be found on the FDA’s website at https://www.fda.gov/advisory-committees/advisory-committee-calendar/october-29-2019-meeting-bone-reproductive-and-urologic-drugs-advisory-committee-meeting-announcement.
About Makena® (hydroxyprogesterone caproate injection)
Makena is a progestin indicated to reduce the risk of preterm birth in women pregnant with a single baby who have a history of singleton spontaneous preterm birth. Makena was approved by the FDA in February 2011 and was granted orphan drug exclusivity through February 3, 2018. In February of 2018, AMAG introduced the prefilled Makena auto-injector containing a short, thin, non-visible needle for subcutaneous use, offering patients and providers a new administration option.
Makena has certain limitations of use. While there are many risk factors for preterm birth, safety and efficacy of Makena has been demonstrated only in women with a prior spontaneous singleton preterm birth. It is not intended for use in women with multiple gestations or other risk factors for preterm birth.
Makena should not be used in women with any of the following conditions: blood clots or other blood clotting problems, breast cancer or other hormone-sensitive cancers, or history of these conditions; unusual vaginal bleeding not related to the current pregnancy, yellowing of the skin due to liver problems during pregnancy, liver problems, including liver tumors, or uncontrolled high blood pressure. Before patients receive Makena, they should tell their healthcare provider if they have an allergy to hydroxyprogesterone caproate, castor oil, or any of the other ingredients in Makena; diabetes or prediabetes, epilepsy, migraine headaches, asthma, heart problems, kidney problems, depression, or high blood pressure.
For additional product information, including full prescribing information, please visit www.makena.com.
AMAG is a pharmaceutical company focused on bringing innovative products to patients with unmet medical needs. The company does this by leveraging its development and commercial expertise to invest in and grow its pharmaceutical products across a range of therapeutic areas, including women’s health. For additional company information, please visit www.amagpharma.com.
AMAG Pharmaceuticals® is a registered trademark of AMAG Pharmaceuticals, Inc.
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