FDA strikes down Mylan's generic Advair—again—citing 'minor' issues
admin 14th June 2018 Uncategorised 0Thought Mylan might snag a generic Advair approval on its second try? Think again. On Wednesday, the company said an FDA rejection for its copy of the GlaxoSmithKline respiratory behemoth was on the way, thanks to “minor deficiencies” in its application. The agency will dig into what those are in a Complete Response Letter, which it’ll issue on June 27.
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Source: fierce