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Aurobindo Receives FDA Approval for Ranolazine ER Tablets 500mg and 1000mg

Published: January 03, 2023

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Ranolazine Extended-Release Tablets, 500mg and 1000mg. Aurobindo Pharma’s Ranolazine Extended-Release Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), RANEXA® Extended-Release Tablets, manufactured by Gilead Sciences Inc.

Ranolazine Extended-Release Tablets are indicated for:

  • The treatment of chronic angina.