Discovery Labs making progress on surfactant manufacturing remediation

By Lisa Kerner

Charlotte, N.C., June 27 - Discovery Laboratories, Inc. said while the investigation is not yet complete, the company is making progress on remediation efforts related to its Surfaxin (lucinactant) New Drug Application.

The company believes remedial actions can be successfully implemented as it works toward approval of Surfaxin for the prevention of Respiratory Distress Syndrome in premature infants in the United States.

Discovery Laboratories' investigation and remediation are the result of the April stability failure of Surfaxin process validation.

As part of the remediation, the company has manufactured two investigation batches of Surfaxin that have passed all of the critical release specification assays while also addressing certain issues associated with the second approvable letter received from the Food and Drug Administration.

Discovery Laboratories is a biotechnology company based in Warrington, Pa.

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