FDA Approves Teva Olanzapine/Fluoxetine Combination (ANDA077528)

The U.S. Food and Drug Administration (FDA) granted approval for application ANDA077528, submitted by Teva Pharmaceuticals USA, Inc. The approval covers an oral capsule that combines the atypical antipsychotic olanzapine with the antidepressant fluoxetine hydrochloride. The product is classified as a human prescription drug and will be marketed under the brand name “OLANZAPINE AND FLUOXETINE.” Four capsule strengths are listed: 6 mg olanzapine/25 mg fluoxetine, 6 mg olanzapine/50 mg fluoxetine, 12 mg olanzapine/25 mg fluoxetine, and 12 mg olanzapine/50 mg fluoxetine. All are prescription‑only and administered orally. The FDA’s labeling submissions (numbers 7, 9, 11, and 13) were approved on 26 February 2021, confirming the product’s labeling is authorized for market entry.