Report: Up to 4 million patients may have received unapproved drugs

NEW YORK The number of patients receiving unapproved prescription drugs appears to be in the millions, according to published reports.

The New York Times reported Friday that as many as 4 million patients may have received nitroglycerin tablets, which are placed under the tongue to stop heart attacks. Drug Store News had reported earlier in the month that the Food and Drug Administration had ordered generic drug makers Glenmark Generics and Konec to stop manufacturing and marketing the tablets.

The FDA’s move came as part of its Unapproved Drugs Initiative, which it started in 2006 to address the issue of prescription drugs marketed without FDA approval. The drugs are also known as “grandfathered drugs” because they entered the market before the FDA adopted its current drug-safety standards, in 1938, and have largely existed in a sort of regulatory limbo since then.

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