MedPath

Hydroxyprogesterone Caproate

Generic Name
Hydroxyprogesterone Caproate
Brand Names
Makena
Drug Type
Small Molecule
Chemical Formula
C27H40O4
CAS Number
630-56-8
Unique Ingredient Identifier
276F2O42F5

Overview

Hydroxyprogesterone caproate is a synthetic steroid hormone that is similar to medroxyprogesterone acetate and megestrol acetate. It is an ester derivative of 17α-hydroxyprogesterone formed from caproic acid (hexanoic acid). Hydroxyprogesterone caproate was previously marketed under the trade name Delalutin by Squibb, which was approved by the U.S. Food and Drug Administration (FDA) in 1956 and withdrawn from marketing in 1999. The U.S. FDA approved Makena from KV Pharmaceutical (previously named as Gestiva) on February 4, 2011 for prevention of preterm delivery in women with a history of preterm delivery, sparking a pricing controversy. In April 2023, the FDA withdrew its approval of Makena and its generics given an unfavorable risk-to-benefit assessment.

Background

Hydroxyprogesterone caproate is a synthetic steroid hormone that is similar to medroxyprogesterone acetate and megestrol acetate. It is an ester derivative of 17α-hydroxyprogesterone formed from caproic acid (hexanoic acid). Hydroxyprogesterone caproate was previously marketed under the trade name Delalutin by Squibb, which was approved by the U.S. Food and Drug Administration (FDA) in 1956 and withdrawn from marketing in 1999. The U.S. FDA approved Makena from KV Pharmaceutical (previously named as Gestiva) on February 4, 2011 for prevention of preterm delivery in women with a history of preterm delivery, sparking a pricing controversy. In April 2023, the FDA withdrew its approval of Makena and its generics given an unfavorable risk-to-benefit assessment.

Indication

本品与戊酸雌二醇配伍作长效注射避孕药,具有排卵抑制作用,每月肌内注射一次,避孕效果肯定。

Associated Conditions

  • Corpus Luteum Insufficiency
  • Premature Births
  • Primary Amenorrhoea
  • Secondary Amenorrhea

FDA Approved Products

Hydroxyprogesterone Caproate
Manufacturer:Amneal Pharmaceuticals of NY LLC
Route:INTRAMUSCULAR
Strength:250 mg in 1 mL
Approved: 2018/08/01
NDC:69238-1797
Hydroxyprogesterone Caproate
Manufacturer:Mylan Institutional LLC
Route:INTRAMUSCULAR
Strength:250 mg in 1 mL
Approved: 2021/11/15
NDC:67457-886
HYDROXYPROGESTERONE CAPROATE
Manufacturer:Sun Pharmaceutical Industries, Inc.
Route:INTRAMUSCULAR
Strength:250 mg in 1 mL
Approved: 2019/04/18
NDC:47335-037
Hydroxyprogesterone Caproate
Manufacturer:American Regent, Inc.
Route:INTRAMUSCULAR
Strength:250 mg in 1 mL
Approved: 2018/07/01
NDC:0517-1767
Hydroxyprogesterone Caproate
Manufacturer:AuroMedics Pharma LLC
Route:INTRAMUSCULAR
Strength:1250 mg in 5 mL
Approved: 2022/06/22
NDC:55150-311

Singapore Approved Products

PROLUTON DEPOT INJECTION 250MG/ML
Manufacturer:Bayer AG (Berlin, Müllerstraβe)
Form:INJECTION
Strength:0.250g/ml
Online:Yes
Approved: 2015/10/27
Approval:SIN14879P

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