Sun Pharmaceutical Industries - US arm - Caraco Pharmaceuticals has received tentative approval from the US Food and Drug Administration (USFDA) for its generic dexmedetomidine hydrochloride injection. Dexmedetomidine is a sedative and anesthetic medication, and provides sedation without causing respiratory depression.
The tentative approval is for 100 microgram/ml strength of the injection marketed as Precedex by Hospira Inc in the US.
Recently, Sun Pharmaceutical Industries’ subsidiary had been granted an approval from USFDA for its abbreviated new drug application to market a generic version of Ultram ER, Tramadol hydrochloride extended release tablets.
Sun Pharmaceutical Industries manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in India, US and several other markets across the world.
