FDA Relies on Drug Listing Information in the Latest Round of Marketed Unapproved Drug Warning Letters

By Kurt R. Karst & Dara Katcher Levy –      

Last week, FDA issued Warning Letters (here and here) to Glenmark Generics (“Glenmark”) and Konec Inc. (“Konec”) for marketed unapproved and misbranded 0.3 mg, 0.4 mg, and 0.6 mg nitroglycerin sublingual tablets.  According to the letters, the companies are in violation of FDC Act § 301(d) and § 505(a) Act because the products are “new drugs” and do not have FDA-approved applications, and the products are misbranded under section FDC Act § 502(f)(1) because “their labeling fails to bear adequate directions for their intended uses.”  The Warning Letters are notable for their reliance on Drug Listing information.

FDA, through the Warning Letters, expects that Glenmark and Konec will cease manufacturing their unapproved nitroglycerin products within 90 days and cease shipping the tablets within 180 days; however, the companies are not required to recall product currently on the market.  Glenmark and Konec have 15 days to respond to FDA with discontinuation plans for the products.  FDA also addressed the issue of the supply of nitroglycerin sublingual tablets in its Q&A, published for consumers of nitroglycerin sublingual tablets. 

Notably, the Warning Letters come from Deb Autor, Director of the Office of Compliance, and cite to drug listing submissions as the basis for the information contained in the letter.  Although Drug Listing information has previously been cited in Warning Letters, it was typically done as an adjunct to cGMP observations resulting from a facility inspection conducted by a District Office. 
 
The electronic drug registration and listing system appears to be giving the Office of Compliance a new mechanism to quickly sort drug listings that appear to be unassociated with any OTC monograph or approved application.  As FDA ramps up its Unapproved Drugs Initiative and as more companies update or initiate drug listings through the electronic system, we can expect to see more Warning Letters directly from the Office of Compliance based solely on drug listing information.