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March of Dimes Welcomes FDA Approval of Progesterone Injections
Date:2/4/2011

WHITE PLAINS, N.Y., Feb. 4, 2011 /PRNewswire-USNewswire/ -- The first-ever drug known to prevent some preterm births, which won market approval today from the Food and Drug Administration, was welcomed by the March of Dimes.

"For the first time, we have an FDA-approved treatment to offer women who have delivered a baby too soon, giving them hope that their next child will have a better chance at a healthy start in life," said Alan Fleischman, MD, senior vice president and medical director of the March of Dimes. "Women who already have had a baby born prematurely should check with their health care provider to see if this treatment is appropriate for them. This treatment is not for everyone."

The FDA approved hydroxyprogesterone caproate injection, commonly known as 17P, which is a synthetic form of a hormone produced during pregnancy. It will be marketed under the brand name Makena™ and given in weekly injections to pregnant women between 16 and 20 weeks gestation and continuing until 37 weeks gestation.

A published study by the March of Dimes, the National Institutes for Health, and the Centers for Disease Control and Prevention, using data from 2002, estimated that if all women eligible for the progesterone injections received them, nearly 10,000 spontaneous premature births might be prevented each year.

Nikki and Densel Fleming's first child, Lauren, was born 3 1/2 months early, weighing only two pounds, one ounce. Lauren was hospitalized for five months, a scary and agonizing time for the Marvin, N.C. couple.  Although they wanted a bigger family, the Flemings knew Lauren's early birth increased the chance that future babies also would be born too soon. Nikki received weekly progesterone injections for her next two pregnancies and their next two children, Erin and Corbin, were born nearly full term.

"I thank the March of Dimes for making high-risk pregnant women aware of  progesterone treatments beca
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SOURCE March of Dimes
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