Sun Pharmaceutical Industries Ltd. on Monday announced that the US Food & Drug Administration (FDA) has granted its subsidiary an approval for its Abbreviated New Drug Application (ANDA) to market Roxicodone, oxycodone hydrochloride tablets.
These oxycodone tablets are therapeutically equivalent to Roxicodone tablets from Xanodyne Pharmaceuticals Inc. and are available in three strengths 5mg, 15,g and 30mg. These strengths of oxycodone tablets have annual sales of approximately US$160mn in the US.
The generic, oxycodone hydrochloride tablets, are used as a painkiller. The product will reach the US market shortly, Sun Pharma said in a statement.