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UPDATE 1-Par Pharma gets FDA nod for generic version of Ultram

Mon Nov 16, 2009 9:31am EST

Stocks

   

* Gets approval to market generic Ultram ER

* Says to begin shipping the drug immediately * Gets 180 days marketing exclusivity

* Shares up 4 pct in pre-mkt trade

Nov 16 (Reuters) - Generic drugmaker Par Pharmaceutical Cos Inc (PRX.N) said it received regulatory approval to market a copycat version of Ortho-McNeil's painkiller, Ultram.

Par got approval from the U.S. Food and Drug Administration to market the 100 milligram and 200 mg strengths of the painkiller tramadol.

Being the first one to file for a marketing approval for generic Ultram, Par would get 180 days of marketing exclusivity for the tablet, commencing at its launch.

The company said it expects to start shipping tramadol immediately.

Ortho-McNeil, a Johnson & Johnson (JNJ.N) unit, sells extended-release tramadol tablets under the brand name Ultram.

Annual U.S. sales of the 100 mg and 200 mg strengths of Ultram ER are about $156 million, according to IMS Health data, Par said.

Shares of the company were up 4 percent to $23.67 in premarket trade. They closed at $22.83 Friday on the New York stock exchange. (Reporting by Krishnakali Sengupta in Bangalore; Editing by Aradhana Aravindan)



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