FDA rebuffs Akzo fertility product
Administration after the agency asked for more information before
approving a ready-to-use version of the firm's fertility drug
Follistim.
Akzo Nobel received a knock-back from the US Food and Drug Administration after the agency asked for more information before approving a ready-to-use version of the firm's fertility drug Follistim (follitropin beta), sold by human pharmaceuticals unit Organon.
The new product, called Follistim AQ Cartridge, is a pen-injector formulation of a liquid form of the product, designed for self-administration by the patient. In contrast, Follistim comes in a powder form that requires reconstitution before injection.
The FDA has said that the dossier for the new version is not approvable in its current form, suggesting that the product may be delayed for some time. Akzo has requested a meeting with the agency to explore the reasons for the rejection.
Both versions of the drug are already sold outside the USA under the Puregon and Puregon Pen brand names.
