CRITICALGLP-1 / Weight LossFDA Warning Letter · September 9, 2025

Try Nova

Atlas ID: 2025-09-fda-try-nova-pdu98u

FDA issued a warning letter to Try Nova (trynovamd.com) in September 2025 after reviewing the company's website and finding that its marketing of compounded semaglutide products contained a false or misleading claim implying equivalence to FDA-approved drugs Wegovy and Ozempic. The claim 'Same active ingredient as Wegovy & Ozempic' was found to misbrand the compounded products under FDCA sections 502(a) and 502(bb), because compounded drugs are not FDA-approved and cannot be represented as equivalent to approved products. FDA demanded a written corrective response within 15 working days and warned that failure to comply could result in seizure or injunction.

Flagged claims (1)

Same active ingredient as Wegovy & Ozempic.

Comparative claim w/o evidence · fda-approved-equivalence-misrepresentation

Required actions (2)

You should take immediate action to address any violations (including, for example, ceasing and desisting from using the language cited above that misbrands the product).

Claim removal

Within fifteen (15) working days of receipt of this letter, please provide a written response to the Office of Compounding Quality and Compliance (OCQC) within the Center for Drug Evaluation and Research (CDER)'s Office of Compliance describing the specific steps you have taken to address any violations.

Response required · 15 days

Source

www.fda.gov · FDA Warning Letter

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