Mylan Stock Sinks 2% After FDA Fails To Approve Its Generic Asthma Medication

Mylan NV shares sank 2.0% in afternoon trade Wednesday after the company said the Food and Drug Administration failed to approve its generic version of the asthma medication Advair Diskus, which is manufactured by GlaxoSmithKline . Advair Diskus, which consists of an inhaler and a combination medication, is used to treat asthma and help individuals with chronic obstructive pulmonary disease. Mylan said it was reviewing the FDA's response and will provide updates "as soon as practicable." Odds of approval were low according to FDA statistics, since the decision was released in time for the FDA's late March goal date, said Raymond James analyst Elliot Wilbur. Two issues could have hindered Mylan's new drug application, EvercoreISI analyst Umer Raffat said Tuesday: a citizen's petition filed by Novartis AG's Sandoz criticizing Mylan's low-dose product and how dated Mylan's phase 3 trial was. "Had FDA denied the Sandoz citizen's petition outright, it may have implied that the FDA does not deem Sandoz's point to be important, and the odds of generic approval today would have been higher," Raffat said. "But, that didn't happen." Mylan shares have risen 8.5% over the last three months, compared with a 5.0% rise in the S&P 500 .

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