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Warning Letter

WL#2267

February 3, 2022

Dear John Copanos:

The United States Food and Drug Administration (FDA) has reviewed your firm’s drug listing information provided to FDA’s electronic Drug Registration and Listing System (eDRLS) for your drug products, “esterified estrogens and methyltestosterone” (NDC 51293-639) and esterified estrogens and methyltestosterone (NDC 51293-640). Our review determined that your firm has selected an incorrect active ingredient to be included in the electronic listing file submitted to FDA. As such your firm is in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as explained below. We note that FDA previously sent your firm two letters, one on October 26, 2021 notifying you of listing deficiencies and a subsequent removal notification on December 10, 2021. As stated in the removal notification letter, the continued deficiencies resulted in your products’ removal from FDA’s Online NDC Directory.

Section 510(j) of the FD&C Act and 21 CFR 207 outline drug registration and listing requirements. Under section 510(j)(1)(C), 21 U.S.C. 360, a firm must include in the listing, among other requirements, “the name and quantity of each active pharmaceutical ingredient in the listed drug.” However, the names of the active ingredients listed in the electronic listing file for both products do not match with the names of the active ingredients found on the copy of the labeling provided with the listing submission. Specifically, the names of active ingredients found in the electronic copy includes conjugated estrogens, while the labeling includes esterified estrogens. These active ingredients are different and not equivalent.

Therefore, your firm has not fulfilled its listing obligations under section 510(j) of the FD&C Act, which is a prohibited act under section 301(p), 21 U.S.C. 360(j) and 331(p). In addition, failure to properly list a drug with FDA also renders it misbranded under section 502(o) of the FD&C Act, and in violation of section 301(a) of the FD&C Act, 21 U.S.C. 352(o) and 331(a).

Complete, accurate and up-to-date establishment registration and drug listing information is essential to promote and protect patient safety. FDA relies on establishment registration and drug listing information for several key programs including drug establishment inspections, supply chain security, and post-market-surveillance. Drug registration and listing information is also widely used outside FDA for purposes such as electronic prescribing and electronic health records, insurance reimbursement, and patient education.

We note that this warning letter only addresses registration and listing issues associated with your products. It is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure, and injunction.

Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.

Your response should be sent to U.S. Food and Drug Administration, Center for Drug Evaluation and Research/Office of Compliance/Office of Unapproved Drugs and Labeling Compliance by e-mail to [email protected]. Please be aware that a manual override may be required for certain types of revisions made to an existing drug listing file. If you receive a validation error or have any questions regarding the contents of this letter, please contact us at [email protected]., for further assistance. Include the case identification number of 2267, on all correspondence.

Sincerely,
/S/
Carolyn E. Becker