US FDA's action on unapproved nitroglycerin tablets hits Glenmark and Konec
This article was originally published in Scrip
Executive Summary
The US FDA has ordered Glenmark Generics of Mahwah, New Jersey, and Konec of Tuscan, Arizona, to stop marketing unapproved nitroglycerin tablets in 0.3mg, 0.4mg and 0.6mg dosages. The action is not a recall, as each product had previously been classified as a grandfathered drug in the US. The agency has taken the action against the products as part of its previously announced "Unapproved Drugs Initiative".