Syndros Oral Solution Approval Announced
July 8, 2016 – The U.S. FDA approved Syndros™ (dronabinol) oral solution, manufactured by Insys Therapeutics. Syndros is a cannabinoid medication indicated to treat adults with anorexia associated with weight loss in patients with AIDS and nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. The recommended dosage and frequency varies depending on the condition being treated and the patient’s ability to tolerate the drug. Insys will launch Syndros after the Drug Enforcement Agency (DEA) completes its controlled substance scheduling review. When available, it will compete with Marinol® (dronabinol capsules, CIII – Solvay/generics).
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and a availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.