FDA Approves Akovaz
April 29, 2016 – The U.S. Food and Drug Administration (FDA) approved Akovaz™ (ephedrine sulfate) for the treatment of clinically significant low blood pressure (hypotension) occurring during surgery while under anesthesia. Manufactured by Flamel Technologies, Akovaz will be supplied as 50mg/mL single-use vials and the recommended dose of 5mg to 10mg should be given as an intravenous bolus after it is diluted. Akovaz contains ephedrine sulfate, an alpha- and beta-adrenergic agonist and a norephinephrine-releasing agent that increases blood pressure. While ephedrine sulfate has been used for many years, Akovaz is the first ephedrine sulfate product to gain FDA approval.
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.