HYDERABAD: City-based pharma major Dr Reddy's Laboratories (DRL) on Saturday informed the bourses that it has launched Donepezil Hydrochloride tablets in the US market following the United States Food and Drug Administration (USFDA) nod. The FDA had approved DRL's abbreviated new drug applications (ANDA) for Donepezil Hydrochloride tablets on May 31, 2011.
"DRL has launched Donepezil Hydrochloride Tablets, a therapeutic equivalent generic version of ARICEPT, in the US market on July 26, 2013, following the approval by the USFDA of DRL's ANDA for Donepezil Hydrochloride Tablets, 23mg," the company statement said.
Donepezil Hydrochloride tablet is used in the treatment of Alzheimer's disease. The durg has been developed by Japanese drug major Eisai and is co promoted by Eisai and US pharma giant Pfizer.
According to industry estimates, the drug has sales of approximately $92.6 million for the last twelve months ending March 2013.
DRL's Donepezil Hydrochloride tablets will be available in bottle count sizes of 30 and 90, it added.
Earlier this month, the company had launched Decitabine injection in the US market. Decitabine injection is used in the treatment of acute myeloid leukemia. The company's product is the copycat version of Dacogen, manufactured and sold by Eisai Inc under license from Astex Pharmaceuticals Inc.