News & Events

CYSTADANE® (betaine anhydrous for oral solution) drug shortage has been resolved

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IMPORTANT DRUG INFORMATION UPDATE

March 5, 2018

Dear Health Care Provider,

Recordati Rare Diseases Inc. (Recordati) is pleased to announce that effective March 12, 2018 the CYSTADANE® drug shortage has been resolved.

There had been a manufacturing issue with CYSTADANE in December 2017, which resulted in an interim shortage of the product in the U.S. market. In order to alleviate the shortage of CYSTADANE in the U.S., Recordati coordinated with the Food and Drug Administration (FDA) to import CYSTADANE product approved for use in the United Kingdom into the U.S. market.

The manufacturing issue has been identified and successfully remediated, normal product manufacturing for U.S. FDA-approved CYSTADANE has resumed, and the drug shortage situation has been successfully resolved. The U.S. specialty pharmacy AnovoRx Group LLC will resume dispensing the U.S. FDA-approved CYSTADANE.

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:

Important Safety Information

Reporting of Adverse Events

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:

Please refer to the FDA-approved package insert for Full Prescribing 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.

Sincerely,

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