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news.Mylan has introduced esomeprazole magnesium delayed-release capsules USP, 20mg and 40mg, the generic version of AstraZeneca's Nexium, in the US for the treatment of gastroesophageal reflux disease (GERD) in adults and children ages one and older.
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The company secured final approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA)for this product to treat GERD.
According to IMS Health, esomeprazole magnesium delayed-release capsules USP, 20mg and 40mg, had sales of about $5.2bn for the 12 months ending 30 June 2015 in the US.
Mylan CEO Heather Bresch said: "Mylan’s launch of Esomeprazole Magnesium Delayed-release Capsules USP represents our continued commitment to expand access to high quality medicine, and we’re pleased to provide patients with another affordable treatment option.
"We look forward to continue delivering on our mission to set new standards in healthcare by expanding our broad portfolio of products in the U.S. and around the world."
Around 268 of Mylan ANDAs that represent $101.3bn in annual sales are still awaiting clearances from the FDA, with 50 of them being potential first-to-file opportunities, signifying $33.4bn in annual brand sales, for the year ending 31 December 2014.
The company offers a portfolio of more than 1,400 generic medications as well as provides a range of antiretroviral therapies to around 50% of HIV/AIDS patients in developing countries.