The drug is actually a reissue of an earlier drug and it received accelerated approval.
The drug called Makena is expected to reduce the risk of preterm delivery in women who have had at least one previous preterm delivery.
Preterm delivery is said to raise the risk of infant complications at birth, lifelong disabilities such as cerebral palsy and even death.
The March of Dimes says the rate of preterm birth has increased more than 35 percent in the last 25 years.
