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Cystaran Approval History

FDA Approved: Yes (First approved October 2, 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

DateArticle
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

Further information

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