Par's Zuplenz receives complete response

FDA issued a complete response letter for an NDA from Par Pharmaceutical Cos. Inc. (NYSE:PRX) for Zuplenz ondansetron orally dissolving film strip to prevent nausea and vomiting associated with chemotherapy, radiotherapy and surgery. According to Par, FDA could not inspect the clinical and analytical sites for a bioequivalence study due to an agency-wide restriction on foreign travel to India. The company said there were no issues related to the study data or film product. FDA indicated it would schedule and perform inspections as soon as possible. ...