# FDA WARNING_LETTER - Metuchen Pharmaceuticals, LLC. - September 03, 2019

Source: https://www.keypedia.com/records/warning_letter/metuchen-pharmaceuticals-llc/20fc6459-2221-47fd-8828-b662124b3517

> FDA WARNING_LETTER for Metuchen Pharmaceuticals, LLC. on September 03, 2019. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Metuchen Pharmaceuticals, LLC.
- Inspection Date: 2019-09-03
- Product Type: Drugs
- Office Name: Office of Prescription Drug Promotion
- Summary: The FDA's Office of Prescription Drug Promotion (OPDP) issued a Warning Letter to Metuchen Pharmaceuticals, LLC, regarding promotional materials for STENDRA® (avanafil) tablets. The review of a direct-to-consumer print ad (STEN-MET-28) and display banners (STEN-MET-02 and STEN-MET-06) revealed false or misleading claims about Stendra's risks and efficacy, misbranding the drug under the FD&C Act (21 U.S.C. 352(a) & (n); 321(n), 331(a); 21 CFR 202.1(e)(3)(ii), (iii); (e)(5); (e)(7)(viii)).

Specifically, the print ad suggested a new, unapproved use: "Treat ED and Reduce Risk of Heart Failure with a PDE-5 Inhibitor," for which Stendra lacks approval and adequate directions for use, further misbranding it (21 U.S.C. 352(f)(1); 331(a); 21 CFR 201.5; 201.100; 201.115; 201.128). This is concerning given Stendra's cardiovascular risks and contraindication in patients with New York Heart Association Class 2 or

## Related Officers

- [Director](https://www.keypedia.com/people/robert-dean/6971bf6a-a3ee-42a5-bc4b-e88ad85df505)

Company: https://www.keypedia.com/companies/metuchen-pharmaceuticals-llc/a4c6ee30-3cde-4ce7-88ba-2083216ac49b

Office: https://www.keypedia.com/offices/office-of-prescription-drug-promotion/ef9d7ac0-99c5-4b8d-9153-cff47ba23edc