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Breckenridge Pharmaceutical Launches Generic of Ambien CR
This is the eighth generic version of the drug to treat insomnia.
Breckenridge Pharmaceutical in Berlin, Conn., has launched zolpidem tartrate extended-release tablets, a generic version of Sanofi’s Ambien CR. The product is manufactured by Centaur Pharmaceuticals. Breckenridge, a subsidiary of Towa Pharmaceutical in Osaka, Japan, will market the product with its own label and offer 6.25 mg and 12.5 mg strengths in bottles of 100.
The FDA had granted final approval of this product’s abbreviated new drug application in June 2020. This is the eighth approval of generic for Ambien, according to Drugs.com.
Ambien CR and its generics had annual sales of $42 million during the 12 months ending May 2021, according to Breckenridge.
About 35% of adults have sleeping problems, according to CDC. People who sleep less than seven hours a night are more likely to have chronic health conditions than those who sleep seven or more hours a night, according to the CDC. These include heart attack, coronary heart disease, stroke, asthma, and chronic obstructive pulmonary disease.
FDA Issues Complete Response Letter for Pz-Cel to Treat Epidermolysis Bullosa
April 22nd 2024Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.
