teva

05 February 2021

Captain Valerie Jensen
Associate Director

Drug Shortage Staff

Food and Drug Administration
WO 22, Room 6204

10903 New Hampshire Avenue
Silver Spring, MD 20993

RE: RESPONSE to FDA Letter of Non-Compliance dated 8 January 2021

NDA 020458
Galzin® (Zinc Acetate capsules 25mg)

Dear FDA Drug Shortage Staff:

Teva Pharmaceuticals USA, Inc. (Teva) is hereby providing this letter in response to the Food and

Drug Administration (FDA) letter dated 8 January 2021, which FDA sent under Section 506C (f) of
the Federal Food, Drug, and Cosmetic Act concerning an interruption in supply of Galzin® (Zinc

Acetate capsules 25mg); NDA 020458. Specifically, this letter stated:

“Zinc acetate capsules, 25 mq, 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 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.“

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Response

The root cause for the interruption in the supply of this product was the unavailability of the
Active Pharmaceutical Ingredient (API) due to an unexpected quality issue. In this response, we
outline the related events, actions, and dates related to this interruption.

On 12 August 2020, our Contract Manufacturer (CMOomTM receivecTMTM lots of
Zinc Acetate, USP, which were for the manufacturing of Galzin®. This quantity of Zinc Acetate,
USP API was sufficient for the planned manufacture of this product for approximately

On 27 August 2020, ®® sampled then lots for release testing and it was noted that select
drums had dense and solidified material and could not be sampled. Specifically, the sampling
thief could not penetrate the material. Aotified Teva of the event on 27 August 2020. The
full inventory of the lots remained in quarantine for further investigation to determine root
cause and to identify if the event was isolated to certain drums, while other drums of the lots
would pass incoming goods testing and release. At this time, there were of stock of
Galzin® available for distribution. The originally scheduled campaign for Galzin® would have

brought the inventory to approximately” based on the typical demand forecast.

On 10 Sep 2020, the analysis of the storage, sampling, transport, and handling of the API lots was
completed together with the API Supplier and the CMO. The impact analysis did not identify any
cause for the hardened material and could not isolate an issue to the affected drums. As a result,
the affected drums could not be dissociated from the balance of the lots that had free-flowing
powder drums. In the absence of a root cause, the Quality Unit concluded that these entire?
lots could not be released for the manufacture of finished drug product. Teva placed an
expedited order for a new lot of API from the API Supplier. The API Supplier confirmed the order

and indicated the supply of new API with an estimated delivery date in December 2020.

As preventative measure and to eliminate any potential for a re-occurrence of this incident, Teva
is comprehensively reviewing and will update our relevant procedures to improve the
identification, escalation and reporting of meaningful disruption in the supply of products that
are for life-supporting, life-sustaining, or intended for use in the prevention or treatment of a
debilitating disease or condition.

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We hope this response adequately addresses the concerns of the Agency as cited in the letter
dated 08 January 2021 related to a delay in drug shortage notification for Galzin® (Zinc Acetate
25 mg). Teva remains committed to the needs of its patients and is committed to working

diligently to supply the commercial market with Zinc Acetate and all medically necessary
products.

, es sa
Li he ci - FEb 202)

David R. Bonilla
Associate Director Commercial Quality USA
Teva Pharmaceuticals

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