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Mayne Lines Up Two, But Misses Out On Myring

 
• By Aidan Fry

Mayne Pharma intends in January to introduce novel formulations of itraconazole and halobetasol in the US; but the Australian firm has been hit in its attempt to bring the Myring generic to the US market.

Itraconazole
Mayne Pharma will soon launch a reformulation of itraconazole in the US • Source: Shutterstock

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...

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