FDA Clears First Generic Tamiflu for Oral Suspension

Megan Brooks


September 15, 2017

The US Food and Drug Administration (FDA) has approved the first generic version of oseltamivir phosphate (Tamiflu, Roche) for oral suspension 6 mg(base)/mL, made by Nesher Pharmaceuticals LLC.

"This first generic is of particular importance in patients that are not able to ingest capsules," the FDA said.

Generic oseltamivir phosphate for oral suspension comes in three doses, 30 mg, 45 mg, and 75 mg, and is indicated for patients aged 2 weeks and older who have had flu symptoms for no more than 48 hours. It is also indicated for the preventiion of influenza in patients aged 1 year and older.

It is not known whether oseltamivir phosphate is effective in people who start treatment 2 days after developing symptoms or who have weakened immune systems, the FDA said. Patients are advised to take oseltamivir phosphate as instructed by their healthcare provider.

The FDA cautioned that oseltamivir is not a substitute for flu vaccination.

The agency also noted that oseltamivir phosphate does not treat or prevent illness caused by infections other than the influenza virus, and it does not prevent bacterial infections that may occur with the flu.

Nausea, vomiting, and headache are among the most common adverse events reported by people who used oseltamivir in clinical trials.

"Generic drugs approved by FDA have the same high quality and efficacy as brand-name drugs. Generic manufacturing and packaging sites must pass the same quality standards as those of brand-name drugs," the FDA said.

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