Merck & Co. is manufacturing the drug, which will be sold as RotaTeq. It will be the first time since 1999 that a rotavirus vaccine will be available, reports The Associated Press.
A similar vaccine made by Wyeth was removed after it caused some cases of a rare bowel obstruction called intussusception.
Despite fears that Merck's vaccine will cause similar problems, an advisory panel unanimously recommended the drug in December.
Up to 70,000 infants and toddlers are hospitalized each year for dehydration and other complications from rotavirus, which causes severe diarrhea and vomiting, reports the AP.
Between 300,000 and 500,000 children die from rotavirus around the world, according to the FDA.
RotaTeq is an orally administered vaccine that can be given to babies at six to 12 weeks of age.
