The FDA issued an approvable letter regarding the treatment in April 2006, stating that it would approve the drug on receipt of additional information. The advice issued did not include a requirement for additional trials. Instead the FDA requested additional information predominantly involving drug product specifications and related controls.
Discovery anticipates filing its formal response to the approvable letter in September or October 2007, followed by a six-month review cycle by the FDA for potential approval of its new drug application for Surfaxin.
Discovery is planning to initiate the manufacture of new Surfaxin process validation batches this week and will submit six months of related stability data in its forthcoming formal response to the approvable letter. Additionally, the FDA indicated that Surfaxin shelf-life will be determined based upon comparative stability data from historical Surfaxin batches.
“With the clarity gained from the FDA meeting, the top priorities now are completing the necessary work to submit our response to the FDA for Surfaxin approval, and advancing Aerosurf, our aerosolized surfactant therapy, into phase II clinical trials,” commented Robert Capetola, president and CEO of Discovery.