Dey and Chiesi's Curosurf OKed by FDA

The US Food and Drug Administration has approved Dey LP and ChiesiFarmaceutici SpA Italy's Curosurf (poractant alfa intratracheal suspension), a porcine lung surfactant indicated for the treatment of respiratory distress syndrome in premature infants, a common cause of neonatal mortality. Curosurf is licensed to Dey, an affiliate of Germany's Merck KGaA, for the US market where it will be launched in the first quarter of next year. The product has been available in Europe since 1992, where it is the best-selling surfactant, according to data from IMS Health. Chiesi says that this is its first product approval in the USA.