Serono Luveris review
Executive Summary
Serono's NDA (21-322) for recombinant luteinizing hormone product Luveris (lutropin alpha for inj.) will be reviewed by FDA's Reproductive Health Drugs Advisory Committee on Sept. 30 for concomitant administration with recombinant human follicle stimulating hormone for the induction of ovulation in infertile women with severe luteinizing hormone or follicle stimulating hormone deficiency. The meeting on both days will begin at 8:30 a.m. at the Hilton in Gaithersberg, Md. [To 1watch a webcast or live video of these meetings, go to FDAAdvisoryCommittee.com]....