FDA approves Johnson & Johnson's pain drug tapentadol

Johnson & Johnson announced that the FDA approved the company's oral analgesic tapentadol to treat moderate-to-severe acute pain in adults. The drugmaker licensed the US marketing rights for the treatment from Grunenthal.

The approval was based on data from more than 2100 patients, according to Johnson & Johnson. The file will now be reviewed by the US Drug Enforcement Agency to determine a scheduling classification for the compound, which Paul Stoffels, head of Johnson & Johnson's pharmaceutical R&D, anticipates will take 60 to 90 days. Company spokesperson Greg Panico stated that it is unclear when the DEA will commence its review.

Wachovia Capital Markets analyst Lawrence Biegelsen has forecast that tapentadol could earn $150 million in yearly revenue by 2010. Shares of the drugmaker increased as much as 5.4 percent.

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