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For the first time, a Food and Drug Administration advisory panel has recommended commercial marketing approval of a pharmacologic agent for inhibition of premature labor.
Results of recent clinical trials with the tocolytic drug ritodrine in this country were termed "very attractive" by David Archer, MD, chairman of the FDA's Advisory Committee on Fertility and Maternal Health Drugs and associate professor of obstetrics and gynecology at the University of Pittsburgh School of Medicine.
Staff members of the FDA's Bureau of Drugs told JAMA MEDICAL NEWS that they were not aware of any major obstacle to acceptance of the panel's recommendation.
Approval of ritodrine is expected to stimulate applications for licensing of the pharmacologically similar drugs terbutaline, fenoterol, and salbutamol for the same indication. All four drugs already have received such approval in other countries.
Premature labor is "the biggest perinatal problem in this country," says William Spellacy, MD, chairman of
FDA considers a first: approval of drug for inhibiting preterm labor. JAMA. 1980;243(13):1313-1314. doi:10.1001/jama.1980.03300390003001