Home » FDA Grants Mylan Tentative Approval for Olanzapine Tablets
FDA Grants Mylan Tentative Approval for Olanzapine Tablets
The FDA has tentatively approved Mylan Pharmaceuticals' abbreviated new drug application for olanzapine tablets in 2.5-, 5-, 7.5-, 10-, 15- and 20-mg strengths.
Mylan's olanzapine tablets are the generic version of Eli Lily's antipsychotic medication, Zyprexa. Final approval is dependent on the resolution of Mylan's ongoing patent litigation with Lilly over Zyprexa.
KEYWORDS Drug Pipeline Alert
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