Luveris® is the first and only pure recombinant human luteinizing hormone (r-hLH) available in the US. It is used in combination with GONAL-f® (follitropin alfa for injection) to stimulate follicular development in infertile hypogonadotropic hypogonadal (HH) women with profound LH deficiency (LH<1.2 IU/L). A definitive effect on pregnancy in this population has not been demonstrated. The safety and effectiveness of concomitant administration of Luveris with any other preparation of recombinant human FSH or urinary FSH is unknown.HH is a rare endocrine deficiency. Women with HH are unable to produce the hormones needed for full development of follicles in the ovaries, ovulation and growth of the lining of the uterus sufficient to support implantation of a fertilized egg and early pregnancy. Luveris® addresses an unmet medical need and has received Orphan Drug exclusivity from the FDA.