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