FDA Approval for Vantrela ER
January 18, 2017 – The U.S. FDA approved Vantrela™ ER (hydrocodone) extended-release tablets, manufactured by Teva Pharmaceuticals. Vantrela ER is indicated to treat intense pain that needs constant long-term drug treatment and that has not been controlled with other therapies. A schedule - CII opioid, Vantrela is formulated to reduce the risk of abuse by ingestion, inhalation, and injection. The tablets, which will be available in 15mg, 30mg, 45mg, 60mg and 90mg strengths, should not be chewed, crushed or dissolved. Recommended dosing is once every 12 hours with upper limits of 90mg per dose and 180mg per day. All opioids, including Vantrela ER, have several boxed warnings, including risks for abuse, addiction, overdose and respiratory depression. They caution about neonatal withdrawal syndrome for babies born to women who used opioids while pregnant, as well. Vantrela ER will be dispensed with a Medication Guide, under a Risk Evaluation and Mitigation Strategy (REMS). Teva has not yet announced its launch or pricing plans.
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 U.S. 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 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.