Alpharma gets generic tramadol go-ahead in USA
Alpharma subsidiary Purepac Pharmaceutical has received approval fromthe US Food and Drug Administration to manufacture and market 50mg tramadol tablets, a generic form of Johnson & Johnson subsidiary Ortho-McNeil's opioid analgesic Ultram for moderate to moderately-severe pain, which Alpharma estimates had sales of around $590 million last year.
Similar approvals were also given for other generic tramadol 50mg tablets from Teva, Par Pharmaceutical and Caraco Pharmaceutical. Teva said it would be launching its product immediately.
Ortho-McNeil also markets a combination product containing tramadol and acetaminophen under the Ultracet brand name for the short-term (five days or less) management of acute pain. Ultracet was approved by the US Food and Drug Administration last August.
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