Sun Pharma announces approval to mkt Sinemet CR tablets

Sun Pharmaceutical Industries Ltd. announced that USFDA has granted approval for the company’s Abbreviated New Drug Application (ANDA) for generic Sinemet CR, an extended release version of carbidopa with levodopa.

Carbidopa with levodopa extended release is indicated for the treatment of Parkinson’s disease and syndrome.

These generic extended release versions of carbidopa with levodopa are bio-equivalent to Sinemet CR® marketed by Bristol-Myers and Squibb Company and will be available as tablets in two strengths: 25 mg carbidopa with 100 mg levodopa and 50 mg carbidopa with 200 mg levodopa.

These strengths of carbidopa with levodopa generic and branded products had annual sales of approximately USD 66 million in the US.

The Company expects to reach the market shortly with these products.

Sourced From: Sun Pharmaceutical Industries Ltd