Mylan comments on Advair Diskus ANDA status

Mylan N.V. recently released a brief statement regarding the status of its Abbreviated New Drug Application (ANDA) for its generic iteration of GlaxoSmithKline's Advair Diskus bronchodilator product.
An ANDA is an application for a U.S. generic drug approval for an existing licensed or approved medication.
The firm stated that it received a response letter from the U.S. Food and Drug Administration regarding its ANDA in relationship to its current target date for achieving compliance with the Generic Drug User Fee Act (GDUFA) and that it is reviewing the material.
Mylan spokespersons said the company is preparing to provide an update on the application once its review is complete and it has communicated further with the FDA about the agency’s feedback. The GDUFA, passed in 2012, was structured to provide more efficient access to safe, effective generic prescription drugs to the public while lowering industry expenses, according to the FDA.
In anticipation of the reauthorization of the Generic Drug User Fee Amendment (GDUFA II), the FDA recently began taking steps to ensure efficient administration of GDUFA for fiscal year 2018.
Mylan N.V. produces both generic and specialty pharmaceutical products, operating from its headquarters in Canonsburg, Pennsylvania with offices in the United Kingdom.