Ambien CR Generics Need Extra Bioequivalence Tests, Sanofi Argues To FDA
Sanofi-Aventis is requesting that FDA require additional bioequivalence tests for generic versions of its insomnia product Ambien CR (zolpidem extended-release)
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Questions about the safety of drugs in the sedative-hypnotic class could warrant additional clinical trials to further evaluate the complex sleep-related behaviors associated with the drugs, FDA said in announcing stronger warnings for the class March 14
The approval of Sanofi-Aventis' Ambien CR (zolpidem extended-release) includes claims for sleep maintenance and long-term use that will allow the insomnia medication to compete against newer agents
Drug makers need to continue investing in early-stage research to unveil the next $1 billion-plus drug, panelists at the Argyle conference agree.