Discovery's Surfaxin delayed by FDA

USA-based Discovery Laboratories has received an "approvable" letter for its drug candidate Surfaxin (lucinactant; Marketletters passim), indicated for the treatment of respiratory distress syndrome in premature infants, from the Food and Drug Administration.

The letter, received on May 1, sets out the criteria that Discovery must meet in order for the FDA to approve its candidate for marketing in the USA. The firm says that it intends to reply to the letter once it has assessed the recommendations.

The FDA had previously completed its pre-approval inspection of Discovery's manufacturing facility in Totowa, New Jersey, and recently issued an Establishment Inspection Report reflecting its success.