DEPARTMENT OF HEALTH AND HUMAN SERVICES 

Food and Drug Administration

Silver Spring MD 20993

 CERTIFIED MAIL-RETURN RECEIPT REQUESTED

Teva Pharmaceuticals USA, Inc. January 6, 2021

Attention: Scott Tomsky

Vice President, Regulatory Affairs

400 Interpace Parkway, Building A

Parsippany, NJ 07054

Dear Sir:

This letter is being sent under Section 506C(f) of the Federal Food, Drug, and Cosmetic Act (FD&C 

Act) for the reasons set forth below.

Section 506C of the FD&C Act requires a manufacturer of a drug product1 that is “life-supporting, lifesustaining, or intended for use in the prevention or treatment of a debilitating disease or condition” to 

notify the Food and Drug Administration (FDA or the Agency) of: (1) a permanent discontinuance in 

the manufacture of the drug; or (2) an interruption of the manufacture of the drug that is likely to lead to 

a meaningful disruption2 in the supply of that drug in the United States; and (3) the reason(s) for such 

discontinuance or interruption of manufacturing (section 506C(a) of the FD&C Act). The notification 

must be submitted at least 6 months prior to the date of the discontinuance or interruption of 

manufacturing, or as soon as practicable thereafter, but in no case later than 5 business days after the 

permanent discontinuance or interruption in manufacturing occurs (section 506C(b) of the FD&C Act;

21 CFR 314.81(b)(3)(iii)(b)(2)). Compliance with the notification requirement is essential to 

facilitating the mitigation and/or prevention of a shortage or potential shortage, and ultimately may 

ensure availability of critical drugs for patients.

If a person fails to submit this required notification within the required timeframe, FDA must issue a 

letter to that person informing the person of the failure to comply with the FD&C Act (section 506C(f) 

of the FD&C Act). 

Zinc acetate capsules, 25 mg, is a product that is “life-supporting, life-sustaining, or intended for use in 

the prevention or treatment of a debilitating disease or condition.” This product is indicated for 

maintenance treatment of patients with Wilson’s disease who have been initially treated with a chelating 

agent. It is our understanding that in September 2020, there was an interruption in the manufacture of 

zinc acetate capsules, 25 mg. This interruption was likely to lead to a meaningful disruption in the 

supply of this drug product in the United States. The Agency learned of a disruption in supply of zinc 

 1 The term “product” refers to a specific strength, dosage form, and route of administration of a drug product (81 Federal 

Register 38915, 38919 (July 8, 2015)). 2 Section 506C(h)(3) of the FD&C Act defines “meaningful disruption” to mean “a change in production that is reasonably 

likely to lead to a reduction in the supply of a drug by a manufacturer that is more than negligible and affects the ability of 

the manufacturer to fill orders or meet expected demand for its product,” and “does not include interruptions in 

manufacturing due to matters such as routine maintenance or insignificant changes in manufacturing so long as the 

manufacturer expects to resume operations in a short period of time.”
acetate capsules, 25 mg, from Teva on October 12, 2020. Our records indicate that Teva did not notify

FDA of the interruption in manufacture of this product prior to the October 12, 2020, communication. 

Accordingly, we are issuing you this letter to notify you of your noncompliance with the FD&C Act.

No later than thirty calendar days after the issuance of this letter, you must submit to the Agency a 

written response setting forth the basis for noncompliance with Section 506C and providing the required 

notification, including the reason(s) for the interruption in manufacturing that led to a disruption in the 

supply of zinc acetate capsule, 25 mg, in October 2020 (section 506C(f)(2) of the FD&C Act). 

No later than forty-five calendar days after the issuance of this letter, FDA will make this letter and your

response to the letter available to the public on FDA’s Drug Shortage website, unless the Agency 

determines that this letter was issued in error, or, after review of your response, determines that there 

was a reasonable basis for noncompliance (section 506C(f)(2) of the FD&C Act). In posting the letter 

and your response on the Drug Shortage website, FDA would protect confidential commercial 

information and trade secrets, if any, as required by applicable law.

If you have further questions, please contact the Drug Shortage Staff at (240) 402-7770.

Please submit all communications regarding this drug product to the following address:

Drug Shortage Staff

Food and Drug Administration

WO 22, Room 6204

10903 New Hampshire Avenue

Silver Spring, MD 20993

Sincerely,

CAPT Valerie Jensen

Associate Director

Drug Shortage Staff

Center for Drug Evaluation and Research

cc: David R. Bonilla, Associate Director, Commercial Quality and Compliance