Sun Pharma announces USFDA approval to market generic Roxicodone® tablets
Sun Pharma has announced that USFDA has granted its subsidiary an approval for its Abbreviated New Drug Application (ANDA) to market generic Roxicodone ®, oxycodone hydrochloride tablets. 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. This product will reach the market shortly. Roxicodone® is a registered trademark of Xanodyne Pharmaceuticals, Inc.
Source: Sun Pharmaceuticals