FDA Withdraws Luveris NDA at Manufacturer’s Request

April 15, 2016

The FDA has withdrawn the NDA for the injectable fertility drug Luveris at the request of the manufacturer.

The company said it was unable to conduct the postapproval trial that was a condition of the drug’s approval. EMD Serono — a division of Merck KGaA — first made the request four years ago, saying “it was not feasible” for the company to conduct the trial.

EMD Serono said it could not complete the trials due to the difficulty in rounding up enough women with hypothalamus-induced hypogonadism. It added that there already were therapeutic alternatives on the market.