Tuesday, April 14, 2009
Sun Pharma gets US FDA nod to market generic Roxicodone tabs
Mumbai- Sun Pharmaceutical Industries Ltd announced that US FDA has granted its subsidiary an approval for its Abbreviated New Drug Application (ANDA) to market generic Roxicodone, oxycodone hydrochloride tablets.This product will reach the market shortly.
These oxycodone tablets are therapeutically equivalent to Roxicodone tablets from Xanodyne Pharmaceuticals Inc, and are available in three strengths: 5 mg, 15 mg and 30 mg. These strengths of oxycodone tablets have annual sales of approximately USD 160 million in the US.
Oxycodone is a narcotic painkiller used in the treatment of moderate to severe pain. Roxicodone is a registered trademark of Xanodyne Pharma.