Posted by Michael Wonder on 12 Mar 2018
Hikma provides an update on the status of its ANDA for generic Advair Diskus
12 March 2018 - Hikma Pharmaceuticals announces that it is has received a response from the United States FDA in relation to its abbreviated new drug application for its generic version of GlaxoSmithKline’s Advair Diskus (fluticasone propionate and salmeterol inhalation powder).
On 11 May 2017, Hikma announced it had received a complete response letter (CRL) from the FDA. In the following months, Hikma worked collaboratively with the FDA and was able to address and clarify the majority of the questions raised. However, there remained an outstanding issue regarding the clinical endpoint study and, in response, the company decided to engage in the FDA’s dispute resolution process.
The FDA has now concluded this process, upholding its original determination and requesting the completion of an additional clinical endpoint study. In anticipation of this as one of the potential outcomes, Hikma has already finalised the planning of a new clinical study and expects to start patient enrolment in the coming weeks. Hikma anticipates being able to submit a response to the FDA with new clinical data as early as possible in 2019.
