Aurobindo Receives FDA Approval for Clozapine Orally Disintegrating Tablets, 12.5 mg, 25 mg, 100 mg, 150 mg, and 200 mg
Published: December 12, 2024
East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Clozapine Orally Disintegrating Tablets, 12.5 mg, 25 mg, 100 mg, 150 mg, and 200 mg. Aurobindo Pharma’s Clozapine Orally Disintegrating Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), FazaClo® Orally Disintegrating Tablets manufactured by Jazz Pharmaceuticals III International Ltd.
Clozapine Orally Disintegrating Tablets are indicated for:
- Treatment-Resistant Schizophrenia
- Reduction in the Risk of Recurrent Suicidal Behavior in Schizophrenia or Schizoaffective Disorder.