Home Medical News FDA finds deficiencies in Mylan's generic Advair

FDA finds deficiencies in Mylan's generic Advair

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June 13, 2018 / 8:52 PM / Updated 6 minutes ago

FDA finds deficiencies in Mylan's generic Advair

(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.

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

Mylan said here 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 $40.00 after the bell.

Reporting by Tamara Mathias in Bengaluru; Editing by Maju Samuel




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Dr Irfanullah Khan Born: 15th July,1994 in Khagram,Dir Upper KPK Pakistan. Others names:Doctor Irfo,Peshoo Education:Pharm-D Scholar Graduated from Abasyn University Peshawar. Occupation:Clinical Pharmacist,Doctor,Entrepreneur. Home Town:Dir Upper Height: 6 feet. Website:Iukmedonline.com

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