(RTTNews) -  Par Pharmaceutical Companies Inc. (PRX: News ) announced that it has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for the 100mg and 200mg strengths of tramadol ER. Ortho-McNeil sells extended-release tramadol tablets under the brand name Ultram® ER. Par has been awarded 180 days of marketing exclusivity, commencing at launch, for being the first to file an ANDA containing a paragraph IV certification for the product.

Annual U.S. sales of the 100mg and 200mg strengths of Ultram ER are approximately $156 million, according to IMS Health data. Par began shipping tramadol ER to the trade upon approval.

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by RTT Staff Writer

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