Mayne Pharma plans during January 2019 to launch both its Tolsura (itraconazole) 65mg capsules and its Lexette (halobetasol) 0.05% foam in the US. But the Australian company’s move to bring the Myring (etonogestrel/ethinylestradiol) generic of Merck & Co’s NuvaRing contraceptive to US consumers has been dealt a blow after the US Food and Drug Administration (FDA) issued a complete response letter (CRL), Mayne’s development partner Mithra has revealed.
Approved by the FDA on 11 December, somewhat earlier than Mayne’s previous forecast of “early calendar year 2019”, Tolsura employs...