Sun Pharma gets USFDA nod for generic Sinemet tablets
Sun Pharmaceuticals today said it has received the approval fo the US health regulator Food and Drug Administration (FDA) for marketing the generic version of Sinemet, carbidopa and levodopa tablets used in the treatment of Parkinson's disease.
US FDA has granted the approval for its Abbreviated New Drug Application (ANDA) to market carbidopa and levodopa tablets in 10 mg / 100 mg, 25 mg / 100 mg and 25 mg / 250 mg strengths, Sun Pharma said in a statement.
These strengths of carbidopa and levodopa tablets have total annual market of $70 million in the US alone.