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Home » FDA Pushes PDUFA Date of Insys’ Syndros Back 3 Months
FDA Pushes PDUFA Date of Insys’ Syndros Back 3 Months
March 29, 2016
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.
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