Generic for Invanz Approved
June 25, 2018 – The U.S. FDA has approved Aurobindo Pharma Limited’s generic for Merck’s Invanz® (ertapenem). Ertapenem is indicated for use in adult and pediatric patients who are at least three months of age to treat moderate to severe infections caused by susceptible bacteria. In adults, ertapenem can also be used to prevent infection resulting from elective colorectal surgery.
Ertapenem is administered via intramuscular (IM) injection or intravenous (IV) infusion. Recommended dosing is 1gm daily in adults and children at least 13 years of age. In children 3 months to 12 years of age, recommended dosing is based on weight. For IM injections, treatment should last no more seven days. Intravenous infusions can be administered for up to 14 days.
Aurobindo has launched their generic at an average wholesale price (AWP) of $1,500 per 10mL vial.
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
- U.S. 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.