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Cystaran Approval History

  • FDA approved: Yes (First approved October 2nd, 2012)
  • Brand name: Cystaran
  • Generic name: cysteamine hydrochloride
  • Dosage form: Ophthalmic Solution
  • Company: Sigma-Tau Pharmaceuticals, Inc.
  • Treatment for: Cystinosis

Cystaran (cysteamine cysteamine ophthalmic solution) is a cystine-depleting agent indicated for the treatment of corneal cystine crystal accumulation in patients with cystinosis.

Development History and FDA Approval Process for Cystaran

Oct  9, 2012Approval Sigma-Tau Pharmaceuticals, Inc. Receives FDA Approval of Cystaran (cysteamine ophthalmic solution) 0.44%
May 17, 2010Sigma-Tau Pharmaceuticals Cysteamine Eye Drop NDA Accepted for Filing

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