Lupin receives FDA approval for generic Roxicodone Tablets

Mumbai, June 14, 2017: Pharma Major Lupin Limited (Lupin) announced today that it has received final approval for its Oxycodone Hydrochloride Tablets USP, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg from the United States Food and Drug Administration (FDA) to market a generic version of Mallinckrodt Inc.’s Roxicodone® Tablets.


Lupin’s Oxycodone Hydrochloride Tablets USP, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg is the AB rated generic equivalent of Mallinckrodt Inc.’s Roxicodone® Tablets. Oxycodone Hydrochloride Tablets USP, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Roxicodone® Tablets had US sales of USD 344 million (IMS MAT March 2017).