About CYSTARAN™’s Manufacturing Delay
In September 2010, the U.S. Food and Drug Administration (FDA) issued a complete response letter to Sigma-Tau Pharmaceuticals, Inc. for CYSTARAN™ (cysteamine hydrochloride ophthalmic solution), a therapy for the treatment of corneal cystine crystals in patients with cystinosis. The final approval has been delayed to allow the third party manufacturer of CYSTARAN™ to meet additional standards of production requested by the FDA. While the FDA’s questions about manufacturing are impacting the timeline for product availability, Sigma-Tau Pharmaceuticals, Inc. is committed to the cystinosis community and is diligently working to reach the final stage of the product’s approval process.  For more information regarding CYSTARAN™ and its pending FDA approval, please contact Lesli King at lesli.king@sigmatau.com.

CRN provides this information merely as a service to the public.  CRN does not endorse any of the private pharmacies listed below.  This information is provided based on recommendations from patients and does not represent medical advice.  Please always consult your own physician regarding healthcare decisions.

The following contacts may be able to help patients with cystinosis obtain cysteamine eye drops:

National Institutes of Health (NIH)Eye Clinic
Alana Temple, RN
Clinical Trials Coordinator
Phone: (301) 402-1369
Email:  templela@nei.nih.gov   

Leiter's Pharmacy
1700 Park Avenue Suite 30
San Jose CA 95126
Toll free (800) 292-6773 or (408) 292-6772
www.leiterrx.com

Aurora Pharmacy
3284 W. Main St.
East Troy, WI 53120
Phone: (262) 642-5800

Mark Drugs Pharmacy
384 E. Irving Park Road
Roselle, IL 60172
Phone: (630) 529-3400
www.markdrugs.com

Premier Pharmacy Labs Inc.
8269 Commercial Way
Spring Hill, FL 34639
Phone: (800) 752-7139
Fax: (800) 868-4978
www.rxnations.com
Email: vet528@tampabay.rr.com   

 Alberta Children's Hospital in Calgary.
(403) 955-7303
Maryanne MacDonald for further information.