Wilzin
Generic name:zinc acetate dihydrate
Dosage form: capsule
Drug class:Minerals and electrolytes
Medically reviewed by Drugs.com. Last updated on Aug 1, 2021.
HEALTHCARE PROVIDER LETTER
IMPORTANT PRESCRIBING INFORMATION
December 11, 2020
Teva Administrative Offices:
Teva Pharmaceuticals USA, Inc.
Morris Corporate Center
400 Interpace Parkway
Parsippany, NJ 07054
Phone: 1-888-838-2872
| Subject: Supply of GALZIN® (Zinc Acetate) 25 mg Capsules to Address Drug Shortage |
Dear Healthcare Professional:
In order to alleviate a critical shortage of GALZIN® (zinc acetate) 25 mg and 50 mg capsules in the United States (U.S.) market for the treatment of Wilson’s disease, Teva Pharmaceuticals USA Inc. (Teva) is coordinating with the U.S. Food and Drug Administration (FDA) to make available in the U.S. the non-FDA approved pharmaceutically equivalent alternative drug, Wilzin® (zinc acetate dihydrate) 25 mg capsules, lot# 30062451, expiration date 10/2022, and lot# 30062461, expiration date 10/2022, for the duration of the shortage and at no cost to patients. The zinc acetate dihydrate capsules marketed in Europe under the brand name Wilzin® by Recordati Rare Diseases are manufactured at the same facility in the U.S. that manufactures GALZIN® which is an FDA-inspected facility that complies with current Good Manufacturing Practice requirements.
At this time, no other entity except Teva is authorized by the FDA to import or distribute Recordati’s Wilzin® (zinc acetate dihydrate) capsules in the U.S. However, this does not represent a formal FDA approval of Recordati’s Wilzin® in the United States. Teva is also working to restock GALZIN® 25 mg and 50 mg capsules in the U.S. market with an anticipated restock date in February 2021.
Effective immediately, Teva will distribute the following presentation of Recordati’s Wilzin® (zinc acetate dihydrate) capsules to address the critical shortage:
| Product Name | Quantity | Capsule Description | Marketing Authorization Number(s) | NDC |
| Wilzin® (zinc acetate dihydrate) capsule, 25 mg | Bottle of 250 capsules | Aqua blue opaque cap and body, imprinted “93-376” | EU/1/04/286/001 (Eur MEDICAL DEPARTMENTS
Cardiology
Pediatrics
Diabetes Care
Pre-natal Care
Ultrasound Echocardiogram
|
