FDA approval for Mylan’s generic version of Advair
Consort Medical plc (LSE: CSRT) (“Consort” or “Consort Medical”), a leading developer and manufacturer of drugs and premium drug delivery devices, notes 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).
Consort has constructed a 5,500 square metre dedicated building and clean room 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. As detailed in our interim results announcement, Consort looks forward to continuing to support Mylan on their product launch.
The Board’s outlook for the Group remains unchanged.
Jonathan Glenn, Consort Medical’s Chief Executive Officer, commented:
“We are delighted that Mylan has received approval for their generic of Advair Diskus, which incorporates Consort’s global market leading expertise in respiratory drug delivery devices, and we look forward to continuing to partner with them on the launch of this product. 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.
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