Luveris lutropin alpha regulatory update

FDA withdrew approval of an NDA for Merck’s infertility drug Luveris lutropin alpha. Merck said it requested the withdrawal in 2012, at which time it stopped marketing the drug in the U.S. According to the company, it was unable to complete a postmarketing trial required under FDA’s 2004 accelerated approval of Luveris “due to the difficulty in recruiting hypogonadotropic hypogonadal women, a small patient population.” ...