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Mylan says disagrees with FDA over generic Advair delay

Reuters - UK Focus

NEW YORK, May 10 (Reuters) - Drugmaker Mylan Inc, which is trying to launch a generic form of GlaxoSmithKline (Other OTC: GLAXF - news) '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 (Hamburg: 27249935.HM - news) 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)