Consort Medical has noted the announcement from the US Food and Drug Administration (FDA) that it has granted abbreviated new drug application (ANDA) approval for Mylan’s WixelaTM InhubTM (fluticasone propionate and salmeterol inhalation powder, USP), the first FDA-approved generic of ADVAIR DISKUS (fluticasone propionate and salmeterol inhalation powder).
The British manufacturer of drugs and drug delivery devices has constructed a 5,500 sqm dedicated building and cleanroom at its King’s Lynn site with appropriate manufacturing capacity to support Mylan in producing the proprietary dry powder inhaler (DPI) for their generic of Advair Diskus.
Jonathan Glenn, Consort Medical CEO, commented: “We are delighted that Mylan has received approval for their generic of Advair Diskus, which incorporates Consort’s expertise in respiratory drug delivery devices, and we look forward to continuing to partner with them on the launch of this product.
He continued: The production of this high volume, premium-quality drug delivery device supports Consort’s well-established strategy of driving sustainable organic growth.”
This development programme is referred to as DEV610 in the Consort development portfolio.