East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Diazepam Tablets USP, 2 mg, 5 mg and 10 mg. Aurobindo Pharma’s Diazepam Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), Valium Tablets manufactured by Waylis Therapeutics LLC.

Diazepam Tablets are indicated for:

• The management of anxiety disorders or for the short-term relief of the symptoms of anxiety
• In acute alcohol withdrawal, diazepam tablets may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis
• A useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma), spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia), athetosis, and stiff-man syndrome
• Oral diazepam tablets may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy.