Preterm Birth

• FDA approval · 2026-04-08
  FDA Approved: PROGESTERONE VAGINAL INSERTS — Original Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved Glenmark's progesterone vaginal inserts as a generic product for the prevention of preterm birth in certain singleton pregnanci…

• FDA approval · 2022-05-24
  FDA Approved: HYDROXYPROGESTERONE CAPROATE — Supplemental Application (AuroMedics Pharma LLC)

  FDA approved a supplemental application for hydroxyprogesterone caproate filed by AuroMedics Pharma LLC.

• FDA approval · 2019-05-09
  FDA Approved: HYDROXYPROGESTERONE CAPROATE — Original Application (AuroMedics Pharma LLC)

  FDA approved AuroMedics Pharma LLC's original application for hydroxyprogesterone caproate, a generic injectable indicated to reduce the ris…