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.