Mylan debuts generic Zyprexa Zydis in USA; Actavis Exalgo copy approved

14 May 2014

US generic drugmaker Mylan (Nasdaq: MYL) says it has launched Olanzapine Orally Disintegrating tablets (ODT), 5mg, 10mg, 15mg and 20mg, the generic version of US pharma major Eli Lilly’s (NYSE: LLY) Zyprexa Zydis tablets.

Mylan received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated for the treatment of schizophrenia or the acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder.

Olanzapine ODT in the specified formulations has US sales of around120.8 million for the 12 months ending March 31, 2014, according to IMS Health quoted by Mylan.

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