FDA Pushes PDUFA Date of Insys’ Syndros Back 3 Months

The FDA has extended the PDUFA date of Insys Therapeutics’ Syndros by three months, from April 1 to July 1.

The company disclosed information related to the scheduling of Syndros under the Controlled Substances Act, and the FDA determined the information to be a significant amendment to the NDA.

Syndros is an oral spray to treat nausea associated with chemotherapy for AIDS patients.