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Mylan Slams FDA For Agency's Handling Of Complex Generic Applications

August 10, 2017
Mylan is pointing the finger at FDA approval delays, and the agency's alleged prioritization of third, fourth and fifth generics over first generics and complex products, for the company's below forecasted quarterly earnings. Due to uncertainty over the FDA process, Mylan is pulling from its 2017 earnings guidance approval of two generic products currently being reviewed by FDA. The generic manufacturer is also facing headwinds due to price erosion, which it says is influenced by generic competition and consolidation in...


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