Nova Vascular LLC dba NOVARX
FDA issued a warning letter to Nova Vascular LLC dba NOVARX (New York, NY) following a March 2026 review of its website, which markets compounded semaglutide and tirzepatide products. The agency found the website made false or misleading claims, including implying FDA approval of compounded drugs by referencing the same active ingredient as Ozempic and describing sourcing from 'FDA Approved Pharmacies,' a designation that does not legally exist for compounding facilities. The product labels also falsely identified 'NOVA RX' as the compounder when it is not. FDA cited misbranding violations under FD&C Act sections 502(a) and 502(bb) and warned that failure to correct violations may result in seizure or injunction.
Flagged claims (3)
…access to the same active ingredient found in Ozempic.
FDA Approved Pharmacies
NOVA RX
Required actions (4)
Send your written response to the Office of Compounding Quality and Compliance (OCQC) within the Center for Drug Evaluation and Research (CDER)'s Office of Compliance at [email protected] within fifteen (15) business days of receipt of this letter.
Addressing other website claims that contain false or misleading representations about your compounded drug products or demonstrating that such claims have been modified or removed in light of FD&C Act §§ 502(a) and 502(bb) [21 U.S.C. §§ 352(a) and 352(bb)].
Identifying the entities that produce the compounded drug products offered on your website;
Providing a representative sample of labeling for such drug products;
Does your site contain similar claims?
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