FDA, Mylan silence on generic Advair may be good news for GSK [Reuters]
GSK plc American Depositary Shares (Each representing two Ordinary Shares) (GSK)
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Source: Reuters
FDA, Mylan silence on generic Advair may be good news for GSK LONDON A deadline for U.S. regulators to give a verdict on a generic copy of GlaxoSmithKline's blockbuster inhaled lung drug Advair has passed with no sign of approval, sparking speculation that a threat to GSK profits might be delayed. That could offer a reprieve for the British group's new chief executive, Emma Walmsley, who takes over in two days. The U.S. Food and Drug Administration (FDA) had been due to decide by March 28 whether to approve the first substitutable generic copy of the two-part drug for asthma and chronic lung disease, made by generics firm Mylan. In the event, the FDA issued no statement and a Mylan spokeswoman said the generic drugmaker had "no comment at this point". "It is possible Mylan might still make an announcement when the U.S. market opens, but I don't think anybody would be surprised if the review period for their product is extended," said Deutsche Bank analyst Richard Parkes. GSK shares i
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- GSK's page on the SEC website