Content about Imidazopyridines

September 17, 2013

The Food and Drug Administration has approved a generic drug for insomnia made by Lupin, the drug maker said.

BALTIMORE — The Food and Drug Administration has approved a generic drug for insomnia made by Lupin, the drug maker said.

The FDA approved zolpidem tartrate extended-release tablets in the 6.25-mg and 12.5-mg strengths, a generic version of Sanofi's Ambien CR.

The branded version of the drug had sales of $366 million during the 12-month period ended in March, according to IMS Health.

 

January 10, 2013

The Food and Drug Administration is ordering the makers of several sleep drugs to lower the dosage due to the risk that they can impair patients the morning after, the agency said Thursday.

SILVER SPRING, Md. — The Food and Drug Administration is ordering the makers of several sleep drugs to lower the recommended dosage due to the risk that they can impair patients the morning after, the agency said Thursday.

The FDA announced that it was requiring the manufacturers of drugs containing the active ingredient zolpidem to lower the current recommended dosage in light of new data showing that the morning after use, the drug can remain in the blood in sufficient quantities to impair activities that require alertness, such as driving.