The specifics of the "minor deficiencies" cited by the FDA will be relayed on June 27, 2018, upon the official issuance of the CRL.
The US Food and Drug Administration (FDA) has sent Mylan a Complete Response Letter (CRL) for its abbreviated new drug application (ANDA) for its generic fluticasone and salmeterol oral inhaler.
The CRL identified “minor deficiencies,” according to Mylan, and as the generic inhaler was granted priority designation, an approval based on the response to the FDA could be granted in a shorter time frame than the standard 90-day time period.
The specifics of the aforementioned minor deficiencies will be relayed on June 27, 2018, upon the official issuance of the CRL.
“Upon receipt of the official Complete Response Letter, we will determine what, if any, impact that it could have on our full year 2018 outlook,” the company declared in a statement.
This is the second CRL received for the inhaler, a generic form of GlaxoSmithKline’s Advair. It was originally submitted to the FDA in December 2015, and Mylan was sent a CRL in March 2017, which did not detail why the therapy was not approved. The inhaler was resubmitted for a second ANDA shortly after.
Advair Diskus, an inhaler glucocorticoid and long-acting beta-2 agonist for asthma patients of a similar age, lost its US patent protection in 2010.