Ferring's Repronex Approval Overturned

Generic competition to Ares-Serono's Pergonal (menotropins forinjection) in the USA has been averted, after a District Court ruled that the Food and Drug Administration's approval of Ferring's Repronex version was invalid.

In reaching its decision, the court concluded that Repronex does not contain the same active ingredients as Pergonal, used in the treatment of both male and female infertility, and awarded a preliminary injunction against sales of the generic. Repronex was approved by the FDA in January.

Judge Stanley Sporkin said that there were some concerns over the safety and efficacy of Repronex. The court was told that the FDA's finding of therapeutic equivalence may cause physicians to switch from Pergonal to Repronex in the middle of the fertility cycle, and that "patients may lose the opportunity for conception and could be exposed to side effects resulting from administration of different menotropins products."