This PAR covers the assessment of an application to reclassify Calci-D chewable tablets from Prescription Only Medicine (POM) to Pharmacy (P) medicine.
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Aeterna Zentaris(TSX:AEZS)(NASDAQ:AEZS) is a specialty biopharmaceutical company commercializing and developing therapeutics and diagnostic tests. The company’s lead product, Macimorelin, is the first and only United States (U.S.) Food and Drug Administration (FDA) and European Commission approved oral test indicated for the diagnosis of adult growth hormone deficiency (AGHD).
Macimorelin is currently marketed in the U.S. under the tradename Macrile through a licence agreement with
Novo Nordisk(NYSE:NVO), where Aeterna receives royalties on net sales. According to a commercialization and supply agreement, the company plans to seek regulatory approvals and then commercialize Macimorelin in Israel.
- Aeterna Zentaris granted exclusive option to negotiate a license of any resulting intellectual property and know-how developed by the University related.