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Blog Exposure - FDA Granted Approval to AMAG’s Makena(R) Subcutaneous Auto-Injector to Reduce the Risk of Preterm Birth in Certain At-risk Women

LONDON, UK / ACCESSWIRE / February 20, 2018 / Active-Investors.com has just released a free research report on AMAG Pharma, Inc. (AMAG) ("AMAG"). If you want access to this report all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=AMAG as the Company's latest news hit the wire. On February 14, 2018, the Company announced that the US Food and Drug Administration (FDA) has approved the Makena® (hydroxyprogesterone caproate injection) subcutaneous auto-injector drug-device combination product as a ready-to-administer treatment to reduce the risk of preterm birth in women pregnant who have previously delivered one preterm baby in the past. The FDA accepted supplemental new drug application (sNDA) for Makena in June 2017. Register today and get access to over 1,000 Free Research Reports by joining our site below:


Active-Investors.com is focused on giving you timely information and the inside line on companies that matter to you. This morning, AMAG Pharma most recent news is on our radar and our team decided to put out a fantastic report on the company that is now available for free below:


The prefilled Makena® auto-injector offers a new administration option for patients and providers and contains a shorter, thinner non-visible needle compared to the intramuscular (IM) Makena® injection.

Makena® Subcutaneous Auto-Injector to be Available in Second Half of March 2018

Makena® was approved by the FDA in February 2011 and remains the first and only FDA-approved treatment option currently available for pregnant women who have had a prior spontaneous preterm birth. The product's seven-year orphan drug exclusivity expired earlier this month, and the Company does not anticipate a generic version of the IM formulation of Makena® to enter the market until mid-year. The subcutaneous auto-injector will be available in the second half of March 2018. The auto-injector will be priced at parity with the IM formulation to help ensure timely and affordable access.

Additionally, AMAG will file a NDA in Q1 2018 for a new chemical entity (bremelanotide) to treat hypoactive sexual desire disorder (HSDD), a common sexual health condition.

Makena® Auto-Injector Developed in Partnership with Antares Pharma

The Company developed the Makena® auto-injector with its device partner Antares Pharma, Inc., which holds issued patents on the auto-injector device and drug-device combination, the last of which expires in 2034. AMAG also holds a US patent directed to subcutaneous administration and dosing of the Makena® auto-injector product which expires in 2036. AMAG will request Orange Book listing of the eligible AMAG and Antares patents.

AMAG Issued New Patent Directed to Subcutaneous Administration of Makena®

In December 2017, AMAG was issued US Patent Number 9,844,558 entitled "Methods of Reducing Risk of Preterm Birth", directed to subcutaneous administration and dosing of Makena®. The patent is expected to expire on May 02, 2036.

AMAG's Second FDA Approval in February

This approval marks the second FDA approval this month for AMAG. On February 05, 2018, FDA approved the Company's application to broaden the existing label for Feraheme® (ferumoxytol injection) beyond the current chronic kidney disease (CKD) indication to include all eligible adult Iron Deficiency Anemia (IDA) patients who have intolerance to oral iron or have had unsatisfactory response to oral iron. The Feraheme label expansion approval was supported by two positive pivotal Phase-3 trials evaluating Feraheme versus iron sucrose or placebo in a broad population of patients with IDA.

About Makena®

Makena® is a prescription hormone medicine (progestin) used to lower the risk of preterm birth in women who are pregnant with one baby and who have delivered one baby too early in the past. Makena® was shown to work based on a lower number of women who delivered babies at less than 37 weeks of pregnancy. There are no controlled trials demonstrating a direct clinical benefit, such as improvement in neonatal mortality and morbidity. Makena® may cause serious side effects including blood clots, allergic reactions, depression, and yellowing of the skin and the whites of the eyes. The most common side effects include injection site reactions (pain, swelling, itching, bruising, or a hard bump), hives, itching, nausea, and diarrhea. The most common side effects reported with the Makena® auto-injector use was injection site pain.

About AMAG Pharmaceuticals, Inc.

Founded in 1981, AMAG is a biopharmaceutical company focused on bringing therapeutics to market that support the health of patients in the areas of maternal health, anemia management, and cancer supportive care. The Company is headquartered in Waltham, Massachusetts, with additional offices in Tucson, Arizona, and San Bruno, California.

Stock Performance Snapshot

February 16, 2018 - At Friday's closing bell, AMAG Pharma's stock advanced 3.06%, ending the trading session at $18.50.

Volume traded for the day: 2.88 million shares, which was above the 3-month average volume of 1.01 million shares.

Stock performance in the last month – up 39.62%; previous three-month period – up 30.28%; past six-month period – up 9.14%; and year-to-date - up 39.62%

After last Friday's close, AMAG Pharma's market cap was at $653.25 million.

The stock is part of the Healthcare sector, categorized under the Diagnostic Substances industry. This sector was up 0.6% at the end of the session.


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