Manufacturing issues still dog A.P. Pharma

Three years ago A.P. Pharma received a complete response letter (CRL) from the FDA saying problems with manufacturing were one of the reasons the agency was not prepared to approve its lead product. Nearly three years later, the Redwood City, CA, company says it has received another CRL and its manufacturing shortcomings continue to plague the process. Manufacturing may be the least of the issues holding up approval of the A.P. Pharma drug for chemotherapy-induced nausea and vomiting (CINV), but "the FDA has requested the refinement of one product quality analytical test method, and that certain deficiencies identified during facility pre-approval inspections be addressed." Reuters points out the FDA also asked A.P. for a study that can test the usability of the drug's syringe system. It also wants additional analysis of the late-stage trial data to reclassify patients by how severed their nausea was.The company said it remains committed to the drug and that it expects a "product launch for the first half of 2014, versus our prior guidance of the second half of 2013." Release | Story | More