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Volume 2 Published - 14:00 UTC    08:00 EST    06-March-2001      
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Back To Vidyya Gonal-F® Multi-Dose Receives FDA Approval For Treatment Of Infertility

Easy-To-Use Presentation Of Leading Infertility Drug To Be Introduced Us This Spring

Serono SA announced yesterday that its US affiliate has been granted marketing authorization from the US Food and Drug Administration (FDA) for a new multi-dose presentation of Gonal-F® (follitropin alfa for injection), the most prescribed gonadotropin for treating infertile couples in the world. Now, Gonal-F Multi-Dose will be available with flexible dosing and a one-step drug preparation process that uses a liquid for use over several days of treatment. Furthermore, Gonal-F® Multi-Dose can be injected more quickly due to reduced drug volume per injection. Gonal-F® Multi-Dose will be introduced this Spring.

Infertility is a disease that affects approximately one in ten couples worldwide. The most common cause of infertility in women is lack of ovulation. Gonal-F® Multi-Dose will be used to stimulate ovulation in women undergoing infertility treatment. It will also be used to stimulate sperm production in men with a rare form of infertility.

"Improvements in infertility treatment make pregnancy possible for the majority of couples who need help to fulfill their dream of having a child. Now, the convenience of one-step drug mixing with Gonal-F® Multi-Dose and a multiple dose liquid for use over several days makes treatment much easier for patients," commented Mike Allen, Executive Vice President, Reproductive Health, Serono Inc. "Serono has pioneered recombinant infertility treatment with the introduction of Gonal-F(R), today's leading infertility drug, in the mid 90s. The addition of Gonal-F® Multi-dose is a further step towards a complete portfolio of efficacious and patient-friendly infertility treatments."

The new Gonal-F® Multi-Dose reduces the current daily drug mixing process for the patient to one single step that produces a ready-to-use solution that can be taken over several days of treatment. Specially designed, customized syringes make it easy for patients to measure daily prescribed doses of Gonal-F® according to their individual needs as well as adjust their dosage during the course of therapy.

Gonal-F® Multi-Dose is injected subcutaneously using a small needle. As an added benefit, because of the reduced volume of drug to be injected with Gonal-F® Multi-Dose, as compared to other gonadotropin formulations, the drug can be administered more quickly and more comfortably.

Gonal-F® Multi-Dose will be supplied in powder form in a vial along with a syringe pre-filled with water for reconstitution. When mixed, the Gonal-F® Multi-Dose liquid formulation, delivers up to fourteen 75 IU doses for use over several days of treatment.

Gonal-F® will remain available in strengths of 37.5, 75, 150 IU for ovarian stimulation. With the introduction of Gonal-F® Multi-Dose 1200 IU, Serono will be able to provide the most dosing options of any gonadotropin infertility treatment.

Side effects may occur with the use of fertility drugs and, therefore, they should only be prescribed by physicians who are thoroughly familiar with infertility problems and their management. Ovarian hyperstimulation syndrome (OHSS), with or without vascular and pulmonary complications, can occur with the use of fertility drugs. Side effects in women using Gonal-F® for ovulation induction may include headache, ovarian cysts and nausea. The most common side effects reported in men using Gonal-F® were acne, breast pain, fatigue and breast enlargement.

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Editor: Susan K. Boyer, RN
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