WALTHAM, Mass., April 04, 2016 (GLOBE NEWSWIRE) — AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today appear that the new single-dose, preservative-free Makena® is now accessible for prescribing. Makena is the alone FDA-approved analysis adumbrated to abate the accident of preterm bearing in women who are abundant with one babyish and who spontaneously delivered one preterm babyish in the past.
The single-dose conception is an amplification of the Makena artefact band and provides the accessibility of a single-use canteen for once-weekly dosing, afterwards the charge for accumulator of a multi-dose vial. Accessible in trays of four, the single-dose conception provides an another package, which allows pharmacists to allocate a month’s accumulation of four single-dose Makena vials or alone single-dose vials for women who are advancing the end of their advance of therapy.
“Single-dose, preservative-free Makena underscores our company’s charge to alert and responding to requests from healthcare providers and patients,” said Nik Grund, controlling carnality admiral and arch bartering administrator at AMAG. “Prior to the approval and commercialization of the new single-dose, preservative-free Makena, healthcare providers and patients who capital a preservative-free conception of hydroxyprogesterone caproate had to use non-FDA-approved, circuitous versions. According to our latest estimates, we accept that about 38 percent of abundant women at accident for alternate preterm bearing are advised with circuitous product. This barrage now offers our barter and their patients an FDA-approved single-dose, preservative-free adaptation of Makena, bogus to accurate FDA standards.”
AMAG has additionally broadcast the operations of its chump abutment center, Makena Affliction Connection, which provides absolute abetment from alpha to accomplishment of processing the Makena decree to accommodate a new feature, “Makena @Home.” This new diplomacy alms facilitates home administering of Makena by a accomplished healthcare able through the payer-preferred home bloom agency. Bazaar analysis indicates that about one-third of clinically adumbrated patients currently accept hydroxyprogesterone caproate injections in the home setting. The Makena Affliction Connection additionally has accustomed adeptness in acknowledging patients during their abundance by aing acceptable patients to a array of abutment services, including a banking abetment diplomacy and a affectionate bloom assistant counseling account that coaches patients on the risks of preterm bearing and the accent of adhering to account Makena injections.
“The barrage of single-dose Makena is an important footfall in our aing bearing development diplomacy for Makena and demonstrates our company’s adherence to convalescent the options accessible to prescribers and patients,” said Dr. Rob Kaper, chief carnality admiral of medical and accurate diplomacy at AMAG. “We are additionally developing a subcutaneous auto-injector for Makena with a targeted authoritative filing in the aboriginal division of 2017.”
About Makena® (hydroxyprogesterone caproate injection)
Makena® is a progestin adumbrated to abate the accident of preterm bearing in women with a article abundance who accept a history of article ad-lib preterm birth. The capability of Makena is based on advance in the admeasurement of women who delivered <37 weeks of gestation. There are no controlled trials demonstrating a absolute analytic benefit, such as advance in neonatal bloodshed and morbidity.
Limitation of use: While there are abounding accident factors for preterm birth, assurance and adeptness of Makena has been approved alone in women with a above-mentioned ad-lib article preterm birth. It is not advised for use in women with assorted gestations or added accident factors for preterm birth.
Important Assurance Advice for Makena (hydroxyprogesterone caproate injection)
Makena should not be acclimated in women with any of the afterward conditions: claret clots or added claret array problems, blight or added hormone-sensitive cancers, or history of these conditions; abnormal l bleeding not accompanying to the accepted pregnancy, yellowing of the bark due to alarmist problems during pregnancy, alarmist problems, including alarmist tumors, or amoral aerial claret pressure. Afore patients accept Makena, they should acquaint their healthcare provider if they accept an abhorrence to hydroxyprogesterone caproate, brush oil, or any of the added capacity in Makena; diabetes or prediabetes, epilepsy, cephalalgia headaches, asthma, affection problems, branch problems, depression, or aerial claret pressure.
In one analytic study, assertive complications or contest associated with abundance occurred added generally in women who accustomed Makena. These included abortion (pregnancy accident afore 20 weeks of pregnancy), stillbirth (fetal afterlife occurring during or afterwards the 20th anniversary of pregnancy), hospital acceptance for preterm labor, preeclampsia (high claret burden and too abundant protein in the urine), gestational hypertension (high claret burden acquired by pregnancy), gestational diabetes, and oligohydramnios (low amniotic aqueous levels).
Makena may account austere ancillary furnishings including claret clots, allergic reactions, depression, and yellowing of the bark and the whites of the eyes. The best accepted ancillary furnishings of Makena accommodate bang armpit reactions (pain, swelling, itching, bruising, or a adamantine bump), hives, itching, nausea, and diarrhea.
For added U.S. artefact information, including abounding prescribing information, amuse appointment www.makena.com.
AMAG is a biopharmaceutical aggregation focused on bringing analysis to bazaar that accommodate bright allowances and advice advance people’s lives. Headquartered in Waltham, MA, AMAG possesses a assorted portfolio of articles to abutment the bloom of patients in the areas of affectionate health, anemia administration and blight admiring care. Through CBR®, the aggregation additionally helps families to bottle bairn axis cells, which are acclimated today in displace anesthetic for assertive cancers and claret altitude and accept the abeyant to comedy a admired role in the advancing development of adorning medicine. For added aggregation information, amuse appointment www.amagpharma.com.
This columnist absolution contains advanced statements aural the acceptation of the Private Balance Litigation Reform Act of 1995 (PSLRA) and added federal balance laws. Any statements independent herein which do not call absolute facts, including, amid others, the accepted allowances of the single-dose canteen of Makena to healthcare providers and patients; expectations for the aing bearing development diplomacy for Makena, including the targeted timing of a authoritative filing for a subcutaneous auto-injector for Makena; estimates for the citizenry actuality advised with circuitous artefact and the abeyant bazaar for the single-dose canteen of Makena; the accepted allowances of the Makena Affliction Connection and [email protected]; AMAG’s adeptness to accommodate bright allowances and advice advance people’s lives; and the abeyant role of bairn axis beef in adorning medicine, are advanced statements which absorb risks and uncertainties that could account absolute after-effects to alter materially from those discussed in such advanced statements.
Such risks and uncertainties include, amid others, those risks articular in AMAG’s filings with the U.S. Balance and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year concluded December 31, 2015 and consecutive filings with the SEC. Any such risks and uncertainties could materially and abnormally affect AMAG’s after-effects of operations, its advantage and its banknote flows, which would, in turn, accept a cogent and adverse appulse on AMAG’s banal price. AMAG cautions you not to abode disproportionate assurance on any advanced statements, which allege alone as of the date they are made.
AMAG disclaims any obligation to about amend or alter any such statements to reflect any change in expectations or in events, altitude or affairs on which any such statements may be based, or that may affect the likelihood that absolute after-effects will alter from those set alternating in the advanced statements.
AMAG Pharmaceuticals® is a registered brand of AMAG Pharmaceuticals, Inc. Makena® is a registered brand of Lumara Bloom IP Ltd. CBR® is a registered brand of CBR Systems, Inc.
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