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|AMAG Pharmaceuticals Announces FDA Approval of New Single-Dose, Preservative-Free Makena® (hydroxyprogesterone caproate injection)|
The single-dose formulation is an expansion of the Makena product line. Packaged in trays of four (a month’s supply), the single-dose formulation provides an alternative package size to the current multi-dose vial, which contains five weekly injections. AMAG currently expects to commercialize the new single-dose, preservative-free formulation of Makena in the second quarter of 2016.
“We are pleased to receive
The new single-dose formulation:
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For more information about Makena, visit www.makena.com.
About Makena® (hydroxyprogesterone caproate injection)
Limitation 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.
Important Safety Information for Makena (hydroxyprogesterone caproate injection)
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.
In one clinical study, certain complications or events associated with pregnancy occurred more often in women who received Makena. These included miscarriage (pregnancy loss before 20 weeks of pregnancy), stillbirth (fetal death occurring during or after the 20th week of pregnancy), hospital admission for preterm labor, preeclampsia (high blood pressure and too much protein in the urine), gestational hypertension (high blood pressure caused by pregnancy), gestational diabetes, and oligohydramnios (low amniotic fluid levels).
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 of Makena include injection site reactions (pain, swelling, itching, bruising, or a hard bump), hives, itching, nausea, and diarrhea.
For additional U.S. product information, including full prescribing information, please visit www.makena.com.
Such risks and uncertainties include, among others, those risks identified in AMAG’s filings with the
AMAG disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.
AMAG Pharmaceuticals® is a registered trademark of