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Aurobindo Receives FDA Approval for Deutetrabenazine Tablets, 6 mg, 9 mg, and 12 mg

Published: December 26, 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 Deutetrabenazine Tablets, 6 mg, 9 mg, and 12 mg. Aurobindo Pharma’s Deutetrabenazine Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), Austedo® Tablets manufactured by Teva Branded Pharmaceuticals Products R&D, Inc.

Deutetrabenazine Tablets are indicated for the treatment of:

  • Chorea associated with Huntington’s disease
  • Tardive dyskinesia in adults.