PharMerica compounds 17P following receipt of a physician's prescription utilizing hydroxyprogesterone caproate
purchased from a FDA-registered supplier.
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.
and its wholly owned subsidiaries, including its flagship product, Makena (hydroxyprogesterone caproate
injection), for $675 million (consisting of $600 million in cash and 3,209,971 newly issued shares of AMAG Pharmaceuticals) and additional contingent consideration of up to $350 million based on achievement of certain sales milestones.
Last year, an injectable progesterone formulation, hydroxyprogesterone caproate
(Makena), was approved to reduce preterm birth in women with a singleton pregnancy who have a history of spontaneous preterm singleton birth.
Wedgewood Pharmacy will continue to compound 17-AlphaHydroxyprogesterone Caproate
(17P) following the Federal Drug Administration's (FDA) January 26 rejection of KV Pharmaceutical Co.
injection), is the only FDA-approved product to reduce the risk of recurrent preterm birth in certain at-risk women.
Makena, a compounded formulation of 17-alpha hydroxyprogesterone caproate
(17P), was approved by the FDA in February 2011, providing for the first time an approved version of product that had previously been compounded in local pharmacies and used to reduce the risk of certain preterm births in patients who had already experienced a prior preterm birth.
Food and Drug Administration ("FDA") issued an approvable letter to Adeza Biomedical for their candidate for prevention of recurrent preterm birth, the synthetic progestogen 17-alpha-hydroxyprogesterone caproate
For the study reported in the abstract, entitled: Prevention of preterm delivery by 17 alpha-hydroxyprogesterone caproate
in asymptomatic twin pregnancies with a short cervix: a randomized controlled trial, Dr.
In this case, the FDA had approved a compounded therapy 17-alpha-hydroxyprogesterone caproate
(17P) to prevent preterm birth.
Food and Drug Administration ("FDA") has issued an approvable letter to Adeza Biomedical for their synthetic progestogen, 17-alpha-hydroxyprogesterone caproate
(trademarked "Gestiva"), Adeza's candidate for prevention of recurrent preterm birth.
Food and Drug Administration (FDA), which issued a Questions and Answers document on June 29 to clarify its June 15, 2012 statement on compounded versions of hydroxyprogesterone caproate
(the active ingredient in Makena).