False & Misleading Claims/Misbranded (Telehealth): FDA Warning Letter to Nova Vascular LLC dba NOVARX, June 8, 2026

FDA Warning Letter — Violations FDA cited at Nova Vascular LLC dba NOVARX

WARNING LETTER Nova Vascular LLC dba NOVARX MARCS-CMS 728290 — June 08, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTED Product: Drugs Recipient: Nova Vascular LLC dba NOVARX 99 Wall Street, #878 New York , NY 10005 United States info@novarx.com Issuing Office: Center for Drug Evaluation and Research (CDER) United States June 8, 2026 WARNING LETTER Reference number: MARCS-CMS 728290 To NOVARX: This warning letter advises you of significant violations identified during a U.S. Food and Drug Administration (FDA) review of your website. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. The violations cited in this letter are not intended to be an all-inclusive list of violations that may exist in connection with your products. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction. FDA Review Violations were identified and documented during a review of NOVARX’s website, https://novarx.co, FDA Establishment Identifier (FEI) 3044022416, in March 2026. FDA observed that your website offers compounded drug products, including semaglutide and tirzepatide products. 1 As described below, your website’s false or misleading claims concerning compounded semaglutide and tirzepatide products under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§ 352(a) and 352(bb)], result in products being introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FD&C Act [21 U.S.C. § 331(a)]. This review was conducted under FDA’s public health responsibilities to protect the public from unsafe, ineffective, and poor quality drug products. Violations of the Federal Food, Drug, and Cosmetic Act The following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations that may exist in connection with your products or operations. Your representations regarding compounded semaglutide and tirzepatide products are false or misleading. Under section 502(a) of the FD&C Act [21 U.S.C. § 352(a)], a drug product is misbranded if its labeling is false or misleading in any particular. Furthermore, under section 502(bb) of the FD&C Act [21 U.S.C. § 352(bb)], a compounded drug product is misbranded if its advertising or promotion is false or misleading in any particular. More specifically, 1. The compounded semaglutide and tirzepatide products displayed on your website identify “NOVA RX” on the pictured label, suggesting NOVARX is the compounder of those drugs when in fact it is not. 2 2. The following claims concerning compounded semaglutide products appear on your website: “…access to the same active ingredient found in Ozempic.” Compounded drug products are not FDA-approved. Your claims represent that the compounded drug products you offer have been FDA-approved or otherwise evaluated for safety and effectiveness when they have not. 3. Your website claims that the compounded drug products it offers are sourced from “FDA Approved Pharmacies.” Compounding facilities, including pharmacies and outsourcing facilities, are not “FDA-approved” or “FDA-licensed” entities. The FD&C Act does not establish an “FDA-approved” or “FDA-licensed” designation for pharmacies or outsourcing facilities. 3 Therefore, representing a compounding pharmacy or outsourcing facility as “FDA-approved” or “FDA-licensed” is false and misleading, as these terms imply a formal authorization that FDA does not grant to such entities or their compounded products. Accordingly, these representations cause your compounded