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Aurobindo Receives FDA Approval for Tofacitinib Extended-Release Tablets, 11 mg

Published: June 03, 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 Tofacitinib Extended-Release Tablets, 11 mg. Aurobindo Pharma’s Tofacitinib Extended-Release Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), Xeljanz XR Extended-Release Tablets manufactured by Pfizer Inc.

Tofacitinib Extended-Release Tablets are indicated for the:

  • Treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more TNF blockers
  • Treatment of adult patients with active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to one or more TNF blockers
  • Treatment of adult patients with moderately to severely active ulcerative colitis (UC), who have had an inadequate response or intolerance to one or more TNF blockers.