Hikma Pharmaceuticals and Vectura announced that the FDA has issued a minor complete response letter regarding Hikma’s ANDA for VR315 fluticasone propionate/salmeterol DPI, a generic version of GSK’s Advair Diskus. The companies say that they “are committed to bringing this important product to the US market and remain confident in the submission.”
Hikma said that the new CRL raises “a small number of questions” and that once the FDA has received the answers, a response would be expected within 90 days. The company said that it now anticipates an approval in early 2021.
The agency previously issued a complete response letter to the company’s ANDA for VR315 in May 2017, and in March 2018, Hikma announced that the FDA had requested an additional clinical trial. Hikma submitted its response to the 2017 CRL in November 2019.
Vectura notes that an FDA approval of VR315 would trigger $11 million in milestone payments as well as royalties on net sales. In 2019, Vectura changed its strategy, announcing that it was transforming itself into an inhalation CDMO in order to become less reliant on milestone payments.
Read the Hikma press release.
Read the Vectura press release.
