by Leonard Konis

Created on: February 15, 2011

 Premature birth is the leading cause of death among newborns. According to the Centers of Disease Control and Prevention: "More than a half million babies in the United States - that's 1 in every 8 - are born premature each year." Babies born premature ("or less 37 weeks - full term is about 40 weeks") risk short term and long term serious health concerns (Including lung problems and learning disabilities.

2), requiring intensive special care. Premature births may be necessary when the mother's life or health is in jeopardy. Notable risk factors increase premature births: Cigarette smoking, alcohol, illicit drug use, previous premature birth, carrying more than one baby, genetics and problem with the cervix or uterus.  1 In February 2011, the Food and Drug Administration approved a Makena (progesterone injection): Reduce the risk of premature birth in women that had pre-term deliveries. 2

  Hologic (Developer & manufacturer of diagnostic technology for women's healthcare - Bedford, Massachusetts - 3) developed Makena: Prevent pre-term births. 4 In January 2010, KV Pharmaceutical Corporation agreed to pay a total of $120 million (Initial payment of $70 million) to Hologic for the drug Makena (Previously referred to as Gestiva). In January 2008, KV Pharmaceutical planned to buy the rights to Gestiva however the agreement was changed, when the FDA did not approve the drug. The amended approved agreement sold the rights of Makena to KV Pharmaceutical Corporation.  5 Makena (trademarked hyproxyprogesterone caproate injection prevent pre-term births, 250 mg/mL. 5) is a synthetic type of progesterone, produced naturally as a hormone during pregnancy. 4 In February 2011, the Food and Drug Administration approved the drug Makena diminish the risk for premature delivery, only for women carrying a single fetus. 6 Deputy Director of the Office of New Drugs in the FDA's Center for Drug Evaluation Research Sandra Kweder, M.D. said: "This is the first drug approved by the FDA that is indicated to specifically reduce this risk (pre-term birth)." 8 However, the FDA required the drug-maker conduct further studies to prove the efficacy of the drug's treatment. 6

  Before pre-term contractions Makena is administered, recommend starting between 16 and 21 weeks. Dr. Errol R. Norwitz, chair of obstetrics and gynecology at Tufts Medical Center said: "We can't stop the uterus once it's gone

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