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Mylan says disagrees with FDA over generic Advair delay
May 10, 2017 / 3:30 PM / 7 months ago

Mylan says disagrees with FDA over generic Advair delay

NEW YORK, May 10 (Reuters) - Drugmaker Mylan Inc, which is trying to launch a generic form of GlaxoSmithKline’s Advair asthma treatment, on Wednesday said it is in disagreement with the U.S. Food and Drug Administration over the standards it must meet.

The FDA sent Mylan a letter earlier this year in which it declined to approve the product, but the company had not previously disclosed the issues at hand. Mylan declined to set a timeline for launch for the product.

Reporting by Caroline Humer; Editing by Chizu Nomiyama

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