First oseltamivir generic to win OK
by John Gever, Managing Editor, MedPage Today September 15, 2017
WASHINGTON — The first generic version of the influenza drug oseltamivir phosphate (Tamiflu) is now approved, the FDA said Friday.
The generic product — made by Nesher Pharmeuticals — comes as a 6-mg/mL oral suspension, making it appropriate for very young as well as older patients.
“[This] is of particular importance in patients that are not able to ingest capsules,” the FDA said in announcing the approval, noting that the product is okayed for patients as young as 2 weeks.
As with the branded version, the generic is indicated for acute treatment within 48 hours of flu-like symptom onset. It can also be used for prevention in patients 1 year and older.
The FDA stressed that the drug should not be used as a substitute for flu vaccination. Also, oseltamivir does not prevent other illnesses, including bacterial infections, that may co-exist with influenza.