FDA Approves First Generic Tamiflu


August 04, 2016

The US Food and Drug Administration (FDA) has approved the first generic version of oseltamivir phosphate (Tamiflu, Roche Group), a go-to antiviral treatment for influenza A and B, the agency announced today.

Oseltamivir is indicated specifically for patients 2 weeks of age and older who have had flu symptoms for no more than 48 hours. It's also indicated to prevent influenza in patients 1 year of age and older. However, the FDA cautioned in a news release that although oseltamivir can be taken prophylactically, it is not a substitute for a flu vaccination.

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

Public health authorities stockpile both oseltamivir as well as zanamivir (Relenza, GlaxoSmithKline), another antiviral, for flu outbreaks, but some scientists say more clinical trials are needed to assess their effectiveness.

When taken in the first 48 hours of becoming ill with influenza, the two antivirals are credited with reducing death in hospitalized patients. In addition, they appear to reduce the duration of flu symptoms by roughly 15 hours, but the evidence doesn't necessarily support routine use for all patients. Except in particularly serious cases, the benefits may not be worth the adverse events.

The FDA said in its news release that it does not know whether oseltamivir is effective in people who start treatment after 2 days of developing symptoms or who have weak immune systems. The agency also noted that the drug doesn't treat bacterial infections that may accompany influenza and doesn't prevent or treat any other infection besides influenza, period.

The dosage forms of the new generic version of oseltamivir, manufactured by Natco Pharma, are the same as for Tamiflu: 30 mg, 45 mg, and 75 mg.

More information about today's announcement is available on the FDA website.

Follow Robert Lowes on Twitter @LowesRobert


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