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Aurobindo Receives FDA Approval for Varenicline Tablets, 0.5 mg and 1 mg

Published: May 02, 2025

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Varenicline Tablets, 0.5 mg and 1 mg. Aurobindo Pharma’s Varenicline Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), Chantix Tablets manufactured by PF Prism C.V.

Varenicline Tablets are indicated:

  • For use as an aid to smoking cessation treatment.