The drug, Makena, is a synthetic version of the hormone progesterone, which is needed to maintain a pregnancy. It’s the only drug with FDA approval to reduce the risk of premature birth.
The announcements follow a recall last month of eyedrops made in India that were linked to an outbreak of drug-resistant infections. One person died and at least five others had permanent vision loss.
The moves announced Wednesday promise critical relief to some people with diabetes who can face annual costs of more than US$1,000 for insulin they need in order to live.