  Discovery Laboratories (Warrington, PA)  could see the end of its struggle to launch its Surfaxin (lucinactant) drug on  the US market soon, as the manufacturing issues it has faced have been  resolved.

  Discovery  announced that process validation batches of Surfaxin, an  engineered version of natural human lung surfactant, have demonstrated acceptable stability  at six months under its comprehensive stability testing protocol. These six-month  stability data will be included, along with other data and information, in a  formal response to the US Food and Drug Administration’s April 2006 approvable  letter. Surfaxin was developed for the  prevention of respiratory distress syndrome in premature infants. 

  This latest development represents the  end of the company’s problems with Surfaxin that began in February 2005 when  the contract manufacturer of Surfaxin, Laureate Pharma, received a notice of  inspectional observations (483 form) from the FDA alerting it to issues  regarding the quality assurances systems, documentation, and controls in the  manufacturing of the drug. To take control of the manufacturing of Surfaxin,  Discovery ended its contract manufacturing agreement with Laureate in December  2005 and bought, for $16 million, the New Jersey facility where Laureate was  producing Surfaxin. 

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Discovery Laboratories (Warrington, PA) could see the end of its struggle to launch its Surfaxin (lucinactant) drug on the US market soon, as the manufacturing issues it has faced have been resolved.