ROCKLAND, MA (June 1, 2004) – A prefilled device with liquid formulation used to treat infertility has been approved by the FDA, according to Serono Inc, here.
Gonal-f RFF Pen is a ready-to-use multi-dose follicle stimulating hormone. It was developed to make treatment easier for patients to deliver the dosage precisely and accurately, Serono said.
Gonal-f RFF Pen is used for induction of ovulation and pregnancy in anovuluatory infertile women in whom the cause of infertility is functional and not due to primary ovarian failure, the company said, adding that it is also indicated for the development of multiple follicles in ovulatory women participating in an Assisted Reproductive Technology program.
Serono expects Gonal-f RFF Pen to be available in the US in the third quarter of this year.Serono Inc. is the US affiliate of Serono, a biotechnology company, headquartered in Geneva, Switzerland.