The FDA has denied a citizen petition filed by Sandoz in October 2016 in which Sandoz challenged the agency’s 2013 bioequivalence recommendations for generic versions of Advair Diskus fluticasone propionate/salmeterol xinafoate.
However, in a copy of the March 10, 2017 response letter posted by Fierce Pharma, the FDA said that it “has made no final determination on whether to approve or not approve any ANDA referencing Advair Diskus 100/50 as its RLD.” The letter says that the petition is “denied without comment on whether we will take the actions you request” because the FDA was required “to take final Agency action on the Petition within 150 days of submission” of a citizen petition.
Sandoz had requested that the agency not approve any ANDA for a generic version of Advair Diskus 100/50 unless:
“(1)Type I error rate is adequately controlled in PK bioequivalence testing, including accounting for Type I error rate inflation caused by batch-to-batch variability of the RLD;
(2) the dose used in PK bioequivalence testing retains the necessary sensitivity to product differences existing at the marketed single inhalation dose of the RLD; and
(3) the sampling schedule used in PK bioequivalence testing is robust and centered around the actual time to maximum plasma concentration of both active ingredients at the marketed dose of the RLD.”
The Fierce Pharma article points out that the FDA made its response letter to Sandoz public one day before the GDUFA date for Mylan’s generic Advair ANDA, which was March 28, 2017. That date has now come and gone without any indication of an approval for Mylan.
Read the FDA response letter.
Read the Fierce Pharma article.
