Replies to post #16057 on Synaptogenix Inc (SNPX)

[rayovacAAA]

AFTER READING ABOUT METUCHEN PHARMACEUTICALS, THE DEAL IS EVEN WORSE FOR NTRP SHAREHOLDERS THAN PREVIOUSLY THOUGHT!!!!!!!!!!!!



METUCHEN PHARMACEUTICALS, LLC


https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/metuchen-pharmaceuticals-llc-590713-08162019

The Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) has reviewed a direct-to-consumer print ad (STEN-MET-28), and Display Banners STEN-MET-02 (banners “02”)1 and STEN-MET-06 (banners “06”) (collectively banners) for STENDRA® (avanafil) tablets, for oral use (Stendra) submitted by or on behalf of Metuchen Pharmaceuticals, LLC (Metuchen)2 under cover of Form FDA 2253. The print ad and banners make false or misleading claims and/or representations about the risks associated with and efficacy of Stendra. Thus, the print ad and banners misbrand Stendra within the meaning of the Federal Food, Drug and Cosmetic Act (FD&C Act) and make its distribution violative. 21 U.S.C. 352(a) & (n); 321(n), 331(a). See 21 CFR 202.1(e)(3)(ii), (iii); (e)(5); (e)(7)(viii). The print ad also provides evidence that Stendra is intended for a new use for which it lacks approval, and for which its labeling does not provide adequate directions for use, which also renders Stendra misbranded or otherwise makes its distribution violative. 21 U.S.C. 352(f)(1); 331(a); see 21 CFR 201.5; 201.100; 201.115; 201.128. These violations are concerning from a public health perspective because they create a misleading impression about the safety and effectiveness of Stendra and suggest a use for which the labeling does not provide adequate directions for safe and effective use of the product.

Failure to correct the violations discussed above may result in FDA regulatory action, including seizure or injunction, without further notice.

Sincerely,
{See appended electronic signature page}
Robert Dean
Director
Division of Advertising & Promotion Review 2
Office of Prescription Drug Promotion