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Aurobindo Receives FDA Approval for Baclofen Tablets USP, 10 mg and 20 mg

Published: July 15, 2021

East Windsor, N.J. –Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Baclofen Tablets USP, 10 mg and 20 mg. Aurobindo Pharma’s Baclofen Tablets USP, 10 mg and 20 mg are an AB-rated generic equivalent to the reference listed drug (RLD), LIORESAL® marketed by Novartis Pharmaceuticals Corp .

Baclofen Tablets are indicated for:

  • The alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity.
  • Patients with spinal cord injuries and other spinal chord diseases.