Teva says FDA accepted NDA for long-acting olanzapine schizophrenia drug
Teva said the FDA accepted its New Drug Application for long-acting olanzapine for schizophrenia, with a decision expected later this year. The company also reported Austedo sales of $2.26 billion in 2025 and plans six biosimilar launches in 2026 and 2027.
Teva's New Drug Application for long-acting schizophrenia drug olanzapine has been accepted by the FDA, with a decision expected later this year. If approved, the long-acting olanzapine injectable suspension is expected to significantly enhance patient adherence, and combined annual sales with Uzedy are projected to exceed $2 billion.
The acceptance of the NDA for long-acting olanzapine was described as the company's most meaningful catalyst. The application covers a long-acting schizophrenia drug, and approval could drive sales growth.
Teva's specialty drug Austedo generated $2.26 billion in sales in 2025, a 34% year-over-year increase. Expectations for 2026 sales are between $2.4 billion and $2.55 billion.
Teva plans to launch six new biosimilars in 2026 and 2027. The company said the launches would further solidify its position as the second-largest player in the biosimilar market.