Johnson & Johnson Painkiller Available After Delay Due to DEA Controlled Substance Classification
Tue, 06/23/2009 - 9:29am
NEW YORK (AP) — Johnson & Johnson said Tuesday its painkiller Nucynta is now on the market, following approval from the Food and Drug Administration and Drug Enforcement Agency. The company said immediate-release Nucynta tablets are available with a prescription in 50 mg, 75 mg, and 100 mg strengths, and is approved to treat moderate to severe acute pain in patients 18 and older. The Food and Drug Administration approved the opioid drug in November, but Johnson & Johnson could not market it before the DEA gave it a controlled-substance classification. The agency ruled that Nucynta, or tapentadol, is a schedule II drug, meaning it has a high potential for abuse, and users may become psychologically or physically dependent on the drug, but it has an accepted medical use.