FDA Approves Final Label for Syndros with CII Designation
The Food and Drug Administration (FDA) approved the final labeling for Syndros (dronabinol oral solution; Insys Therapeutics), which classifies the drug as a Schedule II (CII) controlled substance.
The FDA had initially approved Syndros in July 2016, however at that time, the U.S. Drug Enforcement Agency (DEA) had not yet designated a schedule for the product. Syndros is indicated for the treatment of anorexia associated with weight loss in patients with AIDS, and in the treatment of nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. It is the first FDA-approved dronabinol solution for oral administration, containing the pharmaceutical version of tetrahydrocannabinol (THC). The effectiveness of Syndros was established based on studies of dronabinol capsules.
Syndros will be available as a 5mg/mL oral solution, supplied in multi-dose 30mL bottles; the packaging will contain an oral syringe for dosing. Insys Therapeutics expects to launch the product in August 2017.
For more information call (855) 978-2797 or visit Insysrx.com.