Sun Pharmaceutical gets USFDA nod for Oxycodone HCL tablets

Drug firm Sun Pharmaceutical Industries has informed that the US health regulator Food & Drug Administration (FDA) has finally granted its subsidiary an approval for its Abbreviated New Drug Application (ANDA) to market oxycodone hydrochloride tablets.

The drug is a generic version of Xanodyne Pharmaceuticals' Roxicodone tablet, which is used as a narcotic painkiller in the treatment of moderate to severe pain. The company said that it would launch the products in US market shortly, in the strength of 5mg, 15mg and 30mg.

According to reports, oxycodone tablets have annual sales of approximately US$160 million in the US.

Recently, Sun Pharmaceutical got U. S. Food & Drug Administration approval to make and sell generic versions of anticonvulsant topiramate tablets.

At 3:10 pm, the shares of company were trading at Rs 1148 on BSE, up by Rs 20.90 or 1.85%. The stock hit an intraday high of Rs 1163 and low of Rs 1127.10.