nexium-1
Loading Nexium blister strips onto packing line, Tablets Manufacturing, Macclesfield, UK / Courtesy of AstraZeneca
30 January 2015Generics

Teva gets green light for Nexium generic

The US Food and Drug Administration (FDA) has approved an application by pharmaceutical company Teva to market a generic version of AstraZeneca’s heartburn drug Nexium (esomeprazole magnesium).

It is the first time the FDA has approved an application to sell a generic version of the popular drug.

In a statement on its website following the decision, which was made on Monday (January 26), Teva said it was preparing to launch its product in the “near future”.

Kathleen Uhl, director of the office of generic drugs in the FDA’s centre for drug evaluation and research, said health care professionals and consumers “can be assured” that FDA-approved generic drugs have passed the organisation’s rigorous standards.

“It is important for patients to have access to treatment options for chronic conditions,” Uhl added.

Meanwhile, Nexium has been at the centre of an anti-competition dispute between a number of patient interest groups, including the United Food and Commercial Workers Unions and Employers Midwest Health Benefits Fund, and AstraZeneca and Ranbaxy Laboratories.

In that case, the US District Court for the District of Massachusetts ruled last month that a ‘pay-for-delay’ deal between AstraZeneca and India’s Ranbaxy did not violate anti-competition grounds.

The plaintiffs claimed that the deal, in 2008, resulted in AstraZeneca giving generic maker Ranbaxy nearly $1 billion to delay the launch of its proposed generic. They argued that drug stores and patients had been overcharged by billions of dollars since the agreement, but the court said the payment was not unreasonably anti-competitive.

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