Endometrin is indicated to support embryo implantation and early pregnancy by supplementation of corpus luteal function as part of an Assisted Reproductive Technology (ART) treatment program for infertile women.

General Dosing Information

The dose of Endometrin is 100 mg administered vaginally two or three times daily starting the day after oocyte retrieval and continuing for up to 10 weeks total duration. Efficacy in women 35 years of age and older has not been clearly established. The appropriate dose of Endometrin in this age group has not been determined.

Dosage Forms And Strengths

100 mg vaginal insert is a white to off-white oblong-shaped tablet debossed with “FPI” on one side and “100” on the other side.

Storage And Handling

Each Endometrin Vaginal Insert is a white to off-white oblong-shaped insert debossed with “FPI” on one side and “100” on the other side. Each Endometrin® (progesterone) Vaginal Insert, 100 mg, is packed individually in a sealed foil pouch. These pouches are available in cartons packed:

21 vaginal inserts with 21 disposable vaginal applicators (NDC 55566-6500-3)

Store at 25°C (77°F); excursions permitted between 15-30°C (59-86°F).

Manufactured by: Pharmaceutics International Inc., Hunt Valley, MD 21031, Manufactured for: Ferring Pharmaceuticals Inc., Parsippany, NJ 07054. FDA revision date: 2/26/2008

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