Regulatory Focus™ > News Articles > FDA Approves First Generic Version of Roche’s Blockbuster Flu Treatment

FDA Approves First Generic Version of Roche’s Blockbuster Flu Treatment

Posted 04 August 2016 | By Zachary Brennan 

FDA Approves First Generic Version of Roche’s Blockbuster Flu Treatment

The US Food and Drug Administration (FDA) on Thursday announced that it has approved the first generic version of Roche’s Tamiflu (oseltamivir phosphate), a widely used medication for the treatment of the flu (influenza A and B) in patients two weeks of age and older.

Tamiflu, first approved in 1999, earned Roche more than $3 billion back in 2009 and more than $400 million in 2015, though its effectiveness was questioned back in 2014.

Now, India-based Natco and its marketing partner Alvogen will be able to sell a generic version of the flu treatment in the US, and thanks to a settlement in December 2015, the companies say they will get to market Tamiflu prior to the expiration of its pediatric exclusivity period in February 2017.

Other First ANDA Approvals

In June, FDA approved eight first generics, including Mylan’s generic for Salix Pharmaceuticals’ cholesterol drug Fenoglide (fenofibrate), Fresenius Kabi’s generic of Merck’s nausea treatment Emend for injection (fosaprepitant dimeglumine) and Eurohealth International’s generic version of Spectrum Pharmaceuticals’ chemotherapy toxicity reducer Fusilev (levoleucovorin for injection).

The eight first generic approvals in June follow eight in May, 11 in April, 11 in March, six in February and five in January.

And since March, FDA has been prioritizing abbreviated new drug applications (ANDAs) for which there is currently only one generic manufacturer.

FDA has reduced its ANDA workload by about 500 applications in the first six months of 2016, though a recent research letter recently published in JAMA found that of a sampling of 417 novel therapeutics, 210 were eligible for generic competition and 36 (17%) had no generic drugs approved.

 


Categories: Regulatory News

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