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The agency also noted that compounded drugs, including ones containing hydroxyprogesterone caproate, do not undergo FDA premarket review for safety, effectiveness or quality.

Before Makena was approved, pharmacists sometimes made their own versions by compounding drugs that included the active ingredient, hydroxyprogesterone caproate.

Doctors have been treating pregnant women with the synthetic hormone known as 17-alpha hydroxyprogesterone caproate, or simply 17P, since the 1950s.

Many practicing obstetricians have been prescribing some form of the drug as standard treatment since around 2003, when the smaller clinical trial — a National Institutes of Health study — showed that the synthetic hormone 17-hydroxyprogesterone caproate, or "17P," was effective in preventing preterm delivery in women with a history of preterm labor.

Some of the ingredients for Aruba wave, for instance, include 2-t-butylcyclohexyl acetate, 2,6-dimethyl-7-octen-2-ol, allyl caproate, benzyl salicylate, ethyl 2,2-dimethyl hydrocinnamyl and ethyl hexanoate.