Generic Approved for Tamiflu Oral Suspension
September 14, 2017 – The U.S. FDA has approved Nesher Pharmaceuticals’ generic for Genentech’s Tamiflu® (oseltamivir) oral suspension. It is the first generic for Tamiflu oral suspension to receive FDA approval in the United States. Oseltamivir oral suspension is indicated for treatment of influenza (flu) in patients at least two weeks of age who have had flu symptoms for no more than 48 hours, as well as the prevention of influenza in patients at least one year of age. The approval of an oral suspension generic offers a new treatment option for patients who cannot swallow generic oseltamivir capsules, which have been available in the U.S. since December of 2016. Plans for pricing and a launch date for the oral suspension have not yet been released.
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.