Weltruza (olanzapine) FDA approval for schizophrenia, once-monthly injection: Oct 8, 2026

Weltruza (olanzapine) extended-release injectable suspension (TEV-749) was approved by the FDA on October 8, 2026 for schizophrenia in adults; once-monthly subcutaneous long-acting injectable, 318 mg, 425 mg and 531 mg.

The FDA approved Weltruza (olanzapine) for extended-release injectable suspension, Teva's once-monthly subcutaneous long-acting olanzapine for schizophrenia in adults, on October 8, 2026 (NDA 219007). Teva announced the approval on October 9, 2026.

Run-up into the decision (T-120 → T+5)

Key facts

The FDA's approval letter for NDA 219007 is dated October 8, 2026 (FDA approval letter); Drugs@FDA lists the application as received December 8, 2025. Teva announced the approval on October 9, 2026 (Teva release), stating that Weltruza carries no REMS and no post-injection monitoring requirement. pdufa.bio did not hold a goal date for this application, so no early or late margin is computed.

Run-up figures are the stock's own daily closing path over the 120 trading days before the decision, from our price history. Cohort move is the historical median absolute decision-day move for this market-cap tier. History, not a prediction.

Primary source: FDA approval letter, NDA 219007, October 8, 2026

FDA record of the action: the FDA approved on October 8, 2026, per NDA 219007 ORIG-1 (FDA letter). The sponsor announced it the same day. Action dates on pdufa.bio come from the FDA's own record, not the press release. Every FDA action we hold, by FDA date: FDA approval letters.