FDA withdraws Luveris approval

FDA withdrew approval of an NDA for infertility drug Luveris lutropin alpha at the request of the EMD Serono unit of Merck KGaA (Xetra:MRK). According to FDA, Merck said it was "not feasible" to complete a postmarketing study FDA had required in 2004, when the agency granted accelerated approval to Luveris.

Luveris, a recombinant luteinizing hormone, was approved in combination with Merck's Gonal-f follitropin to stimulate follicular development in infertile hypogonadotropic hypogonadal women with profound luteinizing hormone deficiency. The postmarketing study was intended to determine Luveris' effect on time to clinical pregnancy. ...