&Forest's Infasurf Not Approvable, Says FDA

The US Food and Drug Administration has refused to approve Forest Laboratories' lung surfactant product Infasurf, on the grounds that it is essentially the same product as Abbott Laboratories' Survanta (beractant). Survanta was approved in 1991 under the Orphan Drug Act, and so Abbott has seven years' marketing exclusivity.

Forest has responded by insisting that there are "essential differences" between the two products in terms of chemical content, method of manufacture and pharmacological and clinical activity, and will "continue to pursue the FDA review procedure." Abbott has notified Forest that it considers that Infasurf infringes its patents on Survanta, but Forest's patent counsel maintains that this claim is without merit.

The company is targeting Infasurf as an orphan drug for the prevention and treatment of respiratory distress syndrome in preterm infants. Howard Solomon, president of Forest, noted that the FDA gave no indication that the product would be considered the same as Survanta through the entire investigational period. The next step for the company is to submit both published and unpublished data to the agency confirming the differences between the two products, he said.