FDA finds deficiencies in Mylan's generic Advair

FDA finds deficiencies in Mylan's generic Advair

U.S. drugmaker Mylan NV said on Wednesday that U.S. health regulators could not approve its generic version of GlaxoSmithKline's blockbuster inhaled lung drug, Advair, and cited "minor deficiencies" with the copycat version.

FILE PHOTO - A view shows the U.S. Food and Drug Administration headquarters in Silver Spring
FILE PHOTO: A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland August 14, 2012. REUTERS/Jason Reed/File Photo

REUTERS: U.S. drugmaker Mylan NV said on Wednesday that U.S. health regulators could not approve its generic version of GlaxoSmithKline's blockbuster inhaled lung drug, Advair, and cited "minor deficiencies" with the copycat version.

Mylan said http://newsroom.mylan.com/press-releases?item=123580 it expects to receive a formal complete response letter from the U.S. Food And Drug Administration on June 27 and would determine what impact, if any, it would have on its full-year forecast.

The company's shares fell 4 percent to US$40.00 after the bell.

(Reporting by Tamara Mathias in Bengaluru; Editing by Maju Samuel)

Source: Reuters

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