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FDA Approves Fertility Hormone Pen

Devise Promises Simpler FSH Shots
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March 25, 2004 -- The FDA has approved a fertility-hormone prefilled, pre-mixed cartridge for a self-injection pen, the device's manufacturer said Wednesday.

The Follistim AQ Cartridge is designed for use in the Follistim pen. The device carries a very small needle and a dial-a-dose feature. It's designed for women receiving fertility treatments.

Using the pen device, women can conveniently dose themselves with follicle stimulating hormone or FSH. The hormone is prescribed to women undergoing in vitro fertilization or who wish to induce ovulation to become pregnant.

Other FSH self-injection products require women to measure and mix the medicine.

Follistim comes in two strengths and can provide multiple doses from the same cartridge. It's made by Organon U.S.A. Inc., in Roseland, N.J. Organon is owned by Akzo Nobel NV in the Netherlands.

SOURCE: News release, Organon U.S.A. Inc.

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