AMAG Pharmaceuticals Inc said on Wednesday the U.S. Food and Drug Administration rejected a single dose use of its hormone injection, Makena, the agency's second rejection in six months.

Makena is currently approved and marketed in a multi-dose injection and remains unaffected by FDA's rejection of the single-dose vial.

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The multiple dose is approved to be used to lower premature birth in pregnant women who has had one premature baby.