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Temporary importation of CYSTADANE® (betaine anhydrous for oral solution) to address impending shortage

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IMPORTANT PRESCRIBING INFORMATION

22 December 2017

Dear Health Care Provider,

There has been a manufacturing issue with the CYSTADANE® (betaine anhydrous for oral solution) approved for use and distribution in the United States (“U.S.-labeled CYSTADANE”), which has resulted in an interim shortage of this product in the U.S. market.
In order to alleviate the shortage of CYSTADANE in the U.S., Recordati Rare Diseases Inc. (Recordati) is coordinating with the U.S. Food and Drug Administration (FDA) to increase the availability of CYSTADANE. Recordati has initiated temporary importation of its CYSTADANE product approved for use in the United Kingdom into the U.S. market. This product is manufactured by Orphan Europe SARL in France. At this time, no other entity except Recordati, as the U.S. agent of Orphan Europe SARL, is authorized to import or distribute these products in the United States. FDA has not approved the product manufactured by Orphan Europe SARL’s manufacturing facility in France. The imported CYSTADANE is lot CYP1705. It will be dispensed by the U.S. specialty pharmacy, AnovoRx Group LLC.
There are some key differences between the FDA-approved CYSTADANE and the imported CYSTADANE.

A copy of the FDA-approved full prescribing information is being distributed with the imported CYSTADANE. Please refer to the FDA-approved package insert for full prescribing information. Storage conditions are the same as that of the FDA-approved product. Store at room temperature, 15º – 30ºC (59º – 86ºF). CYSTADANE is for oral use only. Protect from moisture. Keep this and all medications out of the reach of children.

U.S. FDA-approved Indication

CYSTADANE (betaine anhydrous for oral solution) is a methylating agent indicated for the treatment of homocystinuria to decrease elevated homocysteine blood levels. Included within the category of homocystinuria are:

For reporting of adverse events and more information

Any adverse effects or medication issues resulting from the use of this drug or quality issues should be reported to Recordati Rare Diseases Inc. at 1-888-575-8344.

Adverse events or quality problems experienced with the use of this product may also be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax:

Important Safety Information

We are committed to helping address patients’ unmet needs through our corporate mission. If you have questions or concerns regarding this product, please call AnovoRx Group, the specialty pharmacy that dispenses CYSTADANE, at 1-888-487-4703 or Recordati Rare Diseases Medical Information at 1-888-575-8344.

Steven R. Peltier
Vice President, Regulatory & Quality Compliance
Chief Compliance Officer
Recordati Rare Diseases Inc.