K-V Pharmaceuticals has said that Hologic has resubmitted a new drug application for Gestiva (hydroxyprogesterone caproate injection) 250mg/ml to the US Food and Drug Administration (FDA).

The drug could be the first approved by the FDA for the prevention of preterm birth in women who are pregnant with a single child and have previous delivered a baby preterm.

A preterm birth occurs when a baby is born prior to 37 weeks of pregnancy, which increases the risk of numerous medical problems.

K-V Pharmaceuticals has an agreement with US-based company Hologic to secure the rights of Gestiva – commonly referred to as 17P – upon FDA approval.