The Food and Drug Administration (FDA) is cracking down on unapproved nitroglycerin tablets. Of the three nitroglycerin tablets on the market, only Pfizer’s Nitrostat is FDA-approved.
“The FDA has seen significant quality and efficacy problems with unapproved nitroglycerin products,” the FDA said in an FAQ on its website.
Glenmark Generics and Konec will have 90 days to stop manufacturing and 180 days to stop shipping their products. Since this is not a recall, already manufactured products will remain on pharmacy shelves.
The warnings come as the FDA is working through a backlog of unapproved medications, many of which were introduced before the FDA was established in 1938, according to an article in the New York Times.
The FDA recommends that patients on these unapproved products continue to take their medication as directed and contact their physician to obtain a replacement prescription. There should not be a supply problem since Pfizer has adequate capacity to supply the entire market, the FDA said.