Nexium is used for the treatment of gastroesophageal reflux disease (GERD).


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Fda clears first generic esomeprazole for gerd. The first generic esomeprazole can be purchased in the US from Pfizer, and second is available in Europe from the German distributor Bayer). drug was cleared by the European Commission in 2008; and the UK's Medicines Healthcare products Regulatory Agency (MHRA) cleared it in December 2010. However, in 2015 the FDA notified manufacturer of generic that "proprietary data and other proprietary used in the approval process were potentially used in the formulation of active ingredient [esomeprazole]". This means that only one manufacturer can produce the drug for US and European market. It then added that is "not an approved or recognized therapeutic use in the United States". European regulatory body said it would require further scientific review before it would allow the drug to be used in the United Kingdom. "The decision is disappointing," said Paul Maysonet, co-founder of Eisai. "For elesase and the UK pharma sector, we can take some comfort from the fact that some of our most-successful medicines have been cleared for sale both in North America and Europe. However, Eisai has been clear and consistent throughout the approval process – and there's no evidence that the new biosimilar (generic) drugs that might have been approved if the FDA had acted in a different way during this process are any less effective than the original branded-formula drugs. This decision shows again that the Feds still don't get it and their inability to manage the science they're responsible for." The decision is a blow to several elesase companies, including Maysonet's, that have tried to get a biosimilar in some of their products – the "new" type of drug. As I reported last year, more than 500,000 US patients are waiting for new biosimilars with active ingredients as the industry tries to expand its reach. But they have no way of knowing what the next Esomeprazole 50mg $141.03 - $0.78 Per pill drugs in development are because the FDA has failed to make drugs and that work for two types of cancer equally accessible. It is clear that the FDA does not appear to follow proper FDA procedures and do what is right for consumers. The decision is a slap in the face to patients, some of whom esomeprazole spc ireland took the lead in making petition to the FDA. If FDA fails to follow the procedure it has in place to approve the biosimilar drug, how much longer will patients have to wait a new drug? Eisai has no intention of walking over to the FDA and asking for approval of it.

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