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

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