Par Pharma says FDA cleared 2 doses of its generic version of J&J’s pain drug Ultram ER

Par Pharma gets FDA approval for generic Ultram ER

WOODCLIFF LAKE, N.J. — Par Pharmaceutical Co. said Monday it received marketing approval for a generic version of Johnson & Johnson’s extended-release chronic pain drug Ultram ER, and has started shipping the drug.

The Food and Drug Administration approved Par’s generic in doses of 100 milligrams and 200 milligrams, Par said. Rival generic drugmakers will not be able to start selling their versions for 180 days because Par was the first company to seek approval.

Annual U.S. sales of Ultram ER, or tramadol, are about $156 million, Par said. In morning trading, Par stock rose 68 cents, or 3 percent, to $23.51.

Ultram ER is sold by Johnson & Johnson’s Ortho-McNeill division. Shares of New Brunswick, N.J.-based Johnson & Johnson rose 55 cents to $61.98.