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Amneal receives FDA approval for generic painkiller

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HAUPPAUGE, N.Y. Amneal Pharmaceuticals has received approval from the Food and Drug Administration to manufacture a generic version of a painkiller made by Johnson & Johnson, the generic drug maker announced Monday.

Amneal said the FDA had approves its generic tramadol/acetaminophen tablets in the 37.5-mg/325-mg strength. The drug is a generic version of Ultracet, made by J&J subsidiary Ortho-McNeil Janssen. Ultracet had sales of $61 million, according to IMS Health data from June 2009.

The drug is used for short-term treatment of moderately severe acute pain and is a controlled substance in some states. The company began shipping the tablets, made at its Hauppauge, N.Y., plant, on Jan. 25.

“Tramadol/APAP is a logical extension of our well-established tramadol line, which enjoys a solid market share in the industry,” Amneal EVP sales and marketing Jim Luce said. “Our total commitment to rapidly expanding our product portfolio, manufacturing the highest-quality products and delivering outstanding customer service combined to power Amneal’s prescription growth of 114% from 2008 to 2009, the highest in the generics industry, according to IMS Health.”

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