Final FDA approval for Mylan's ondansetron
Mylan Pharmaceuticals has received final approval from the US Food and Drug Administration for its Abbreviated New Drug Applications for ondansetron HCl tablets, 4mg (base), 8mg (base) and 24mg (base), and orally disintegrating tablets USP, 4mg and 8mg.
The first is the generic version of UK-based drug major GlaxoSmithKline's Zofran, which had US sales of around $744.0 million for the same strengths over the 12-month period ending March 31, according to IMS Health. GSK's Zofran ODT tablets generated turnover of about $348.0 million for the same strengths for the like 12-month period. These products will be shipped immediately, Mylan stated.
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